Protection of Conscience Project
Protection of Conscience Project
www.consciencelaws.org
Service, not Servitude

Service, not Servitude

HHS Protection of Conscience Regulation (2008-2011)
U.S. Department of Health and Human Services
Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law

Comment by HHS on Final Rule (2008)

Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations: Part VI, 78072-78101.

 

Note:

This submission refers to a regulation issued in December, 2008 by the Bush Administration that was eviscerated by the Obama Administration and re-issued in February, 2011. [See current regulation.]

Headings/comments in [square brackets] added by Project Administrator for convenience.

III.    Legal Authority

On the basis of the following statutory authority, the Secretary promulgates these regulations, requiring certification of compliance with anti-discrimination statutes.

5 U.S.C. 301 empowers the head of an Executive department to prescribe regulations ''for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.''

The Church Amendments, 42 U.S.C.300a-7 (2000), prohibit recipients of Department funding under the PHS Act and several other statutes from discriminating against employees and others who participate in health service programs or research activities funded in whole or part by the Department who refuse to perform certain medical services, including sterilization, abortion, or research activities because of religious or moral beliefs.

Specifically, section 300a-7(c)(1)(A) and (B) provides that recipients may not discriminate in the employment of or the extension of staff privileges to any health care professional because he refused, because of his religious beliefs or moral convictions, to perform or assist in the performance of any sterilization or abortion procedures.

Section 300a-7(d) provides that no individual shall be required to perform or assist in the performance of any health service program or research activity funded in whole or part by the Department contrary to his religious beliefs or moral convictions.6

PHS Act § 245, 42 U.S.C. 238n (1996),prohibits the Federal government and any State or local government that receives federal financial assistance from discriminating against any healthcare entity (including both individual and institutional providers) on the basis that, among other things, the entity refuses to (1) receive training in abortion; (2) provide abortion training;(3) perform abortions; (4) provide referral for such abortions; and (5) provide referrals for abortion training.42 U.S.C. 238n(a).

The Weldon Amendment, Consolidated Appropriations Act, 2008,Public Law 110-161, § 508(d), 121 Stat.1844, 2209 (2008), prohibits a federal agency or program, or any State or local government from receiving Department funds if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions. These statutory provisions require that the Department and recipients of Department funds refrain from discriminating against institutional and individual health care entities for their participation or refusal to participate in certain medical services or research activities funded by the federal government. The Department has authority to promulgate regulations to enforce these prohibitions. Finally, the Department also has the legal authority to require that recipients certify their compliance with these proposed requirements and to require their subrecipients to likewise certify their compliance with these proposed requirements.

We respond to the Comment on the Department's legal authority to promulgate these regulations in section H (General Comments) of the Comments section above.


IV.    Section-by-Section Description of the Final Rule

Section 88.1 Purpose

Proposed Rule: In the proposed rule, the ''Purpose'' section set forth the objective that this final rule provides for the implementation and enforcement of federal nondiscrimination statutes protecting the conscience rights of health care entities. It also states that the statutory provisions and regulations contained in this Part are to be interpreted and implemented broadly to effectuate these protections.

The Department received no Comments on this section.

Final Rule: The Department adopts this provision as recommended in the proposed rule without modification.


Section 88.2 Definitions
Assist in the Performance

Proposed Rule: The Department, in considering how to interpret the term' 'assist in the performance,'' sought to provide broad protection for individuals. At the same time, the Department sought to guard against potential abuses of these protections by limiting the definition of ''assist in the performance'' to only those individuals who have a reasonable connection to the procedure, health service or health service program, or research activity to which they object.

Therefore, the Department proposed to interpret this term broadly, as encompassing individuals who are members of the workforce of the Department-funded entity performing the objectionable procedure. When applying the term ''assist in the performance'' to members of an entity's workforce, the Department proposed that the term be limited to participation in any activity with a reasonable connection to the objectionable procedure, including referrals, training, and other arrangements for the procedure, health service, or research activity. For example, an operating room nurse would assist in the performance of surgical procedures; an employee whose task it is to clean the instruments used in a particular procedure would also be considered to assist in the performance of the particular procedure under the proposed rule.

The Department responds to Comments on the proposed definition of this term above.

Final Rule: The Department adopts the above definition as proposed.

Health Care Entity/Entity

Proposed Rule: While both PHS Act§ 245 and the Weldon Amendment provide examples of specific types of protected individuals and health care organizations, neither statute provides an exhaustive list of such health care entities.

PHS Act § 245 defines ''healthcare entity'' as ''includ[ing] an individual physician, a postgraduate physician training program, and a participant in a program of training in the health professions.'' As a matter of statutory construction as well as long standing Departmental interpretation, the definition of ''health care entity'' in PHS Act § 245 also encompasses institutional entities, such as hospitals and other entities.

The Weldon Amendment defines the term ''healthcare entity'' as ''includ[ing] an individual physician or other healthcare professional, a hospital, a provider sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.''

The Church Amendment does not define the term ''entity,'' and does not use the term ''health care entity.'' In keeping with the definitions inPHS Act § 245 and the Weldon Amendment, the Department proposed to define ''health care entity'' to include the specifically mentioned types of individuals and organizations from the two statutes, as well as other types of entities referenced in the Church Amendments.

The Department responds to Comments on the proposed definition of this term above.

Final Rule: The Department adopts the proposed definition without modification. It is important to note that the Department does not intend for this to be a comprehensive list of relevant types of individuals and organizations for purposes of the regulation, but merely a list of examples.

Health Service/Health Service Program

Proposed Rule: One of the provisions in the Church Amendments uses the term ''health service,'' another uses the term ''health service program.'' The Church Amendments do not define these terms, nor does the Public Health Service Act define ''health service program.'' In developing an appropriate definition for ''health service program,'' the proposed rule looked at the Social Security Act.

Section 1128B(f)(1) of the Social Security Act, 42 U.S.C. 1320a-7b(f)(1), defines a similar term, ''federal health care program'', as ''any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government.'' Building on this broad definition, it was proposed that the term ''healthservice program'' should be understood to include an activity related in any way to providing medicine, health care, or any other service related to health or wellness, including programs where the Department provides care directly (e.g., Indian Health Service); programs where grants pay for the provision of health services (e.g., Administration for Children and Families programs such as the Unaccompanied Refugee Minor and the Division of Unaccompanied Children Services programs and HRSA programs such as community health centers); programs where the Department reimburses another entity that provides care (e.g., Medicare); and health benefit programs where federal funds are used to provide access tohealth coverage (e.g., SCHIP, Medicaid, and Medicare Advantage).

The Department responds to Comments on the proposed definition of this term above.

Final Rule: Upon further reflection, the Department has determined that the meaning of the term ''health service'' is self-evident, and so we do not adopt a definition for ''health service'' in this final rule.

Final Rule: The Department adopts the above definition without modification.

Individual

Proposed Rule: For the purposes of the new proposed part, the proposed rule defined ''individual'' to mean a member of the workforce (see definition of ''workforce'' below) of an entity or health care entity. One conscience clause of the Church Amendments, 42U.S.C. 300a-7(d), provides that ''[n]o individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by the Secretary of Health, Education and Welfare [Secretary of Health and Human Services] if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions.'' (Emphasis added.)

The Department responds to Comments on the proposed definition of this ter above.

Final Rule: The Department adopts the above definition as proposed.

Instrument

Proposed Rule: The proposed rule uses the term ''instrument'' to mean the variety of means by which the Department conveys funding and resources to organizations, including: grants, cooperative agreements, contracts, grants under a contract, and memoranda of understanding. The proposed definition of ''instrument'' was intended to include all means by which the Department conveys funding and resources.

No Comments were received on the definition of this term.

Final Rule: The Department adopts the above definition without modification.

Recipient

Proposed Rule: The proposed rule defined this term to mean any entity that receives Department funds directly.

The Department responds to Comments on the proposed definition of this term.

Final Rule: The Department adopts this definition as proposed


Sub-recipient

Proposed Rule: The proposed rule defined this term to mean any entity that receives Department funds indirectly through a recipient or subrecipient.

The Department responds to Comments on the proposed definition of this term above.

Final Rule: The Department adopts this definition as proposed.

Workforce

Proposed Rule: In the proposed rule we defined the term ''workforce'' as including employees, volunteers, trainees, and other persons whose conduct, in the performance of work for an entity, is under the control orauthority of such entity, whether or notthey are paid by the Department-funded entity. The definition was drawn from the ''Administrative Data Standards and Related Requirements'' rules implementing the Health Insurance Portability and Accountability Act (HIPAA), 45 CFR parts 160, 162, and164 (2006) at 45 CFR 160.103.

In keeping with this definition, persons and organizations under contract with an entity, if they are under the control or authority of the entity, would be considered members of the entity's workforce.

The Department responds to Comments on the proposed definition of this term above.

Final Rule: In response to public Comments on this issue, we have provided an exclusive definition of the term ''workforce'' by changing' 'includes'' to ''means'' in the definition.

In defining both ''individual'' and ''workforce,'' the Department promulgates definitions that provide a reasonable scope for the natural persons protected by 42 U.S.C. 300a-7(d) and the corresponding provisions of these regulations. By limiting the scope of persons protected by these regulations to those who are under the control or authority of an entity that implements a health service program or research activity funded in whole or in part under a program administered by the Department, we provide the bright line necessary for Department-funded entities subject to the applicable Church Amendment provisions to set policies or otherwise take steps to secure conscience protections within the workplace and, thus, to comply with the Church Amendment and these regulations.

As indicated in the proposed rule-and consistent with the scope of the Church Amendments, which include physicians and other health care providers that have privileges with an entity receiving funding from the Department-we intended the concept of ''workforce'' to include physicians and other health care providers who have privileges at the entity funded by the Department. After publication of the proposed rule, it came to the Department's attention that the language of the ''workforce'' definition may not be clear on this issue. Accordingly, to ensure clarity on this point, we are revising the definition of ''workforce'' by adding at the end ''or health care providers holding privileges with the entity''.

Section 88.3 Applicability

Proposed Rule: The ''Applicability'' section of the proposed rule directs individuals and entities receiving funds from the Department to the appropriate sections of proposed section 88.4 that set forth the relevant requirements, drawn from the three statutes that form the basis of this regulation, that are applicable to them and also directed to the provisions regarding certifications that the various recipients of federal monies must provide.

Final Rule: In this final rule, we have included a technical correction in section 88.3 clarifying that educational institutions, teaching hospitals, and programs for the training of health care professionals or health care workers shall comply with section 88.4(c)(2),which prohibits discrimination against or denial of admission to applicants' 'because of reluctance or willingness to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to or consistent with the applicant's religious beliefs or moral convictions'' in accordance with PHS Act § 245. 42 U.S.C. 300a-7(e).Apart from this change, we have adopted this provision as recommended in the proposed rule.

Section 88.4 Requirements and Prohibitions

Proposed Rule: The ''Requirementsand Prohibitions'' section in the proposed rule explains the obligations that the Church Amendments, PHS Act§ 245, and the Weldon Amendment impose on entities which receive funding from the Department, depending on the type of entity and the program or statute under which the funding is received. These provisions are taken from the relevant statutory language and make up the elements of the certification provided by the entities. The proposed rule states that we intend for the requirements and prohibitions to be interpreted using the definitions contained in section 88.2.

Final Rule: The final rule adopts this provision without change.

Section 88.5 Written Certification of Compliance

Proposed Rule: In the ''WrittenCertification of Compliance'' section of the proposed rule, the Department proposed to require certain recipients and sub-recipients of Department funds to certify compliance with the Church Amendments, PHS Act § 245, and the Weldon Amendment, as applicable, and to provide for the affected recipients and sub-recipients requirements for collecting, maintaining, and submitting written certifications.

We are concerned that there is a lack of knowledge on the part of States, local governments, and the health care industry of the rights of health care entities created by, and the corresponding obligations imposed on the recipients of certain federal funding by, the nondiscrimination provisions. Under the proposed rule, recipients of federal funds would be required to submit their certifications directly to the Department as part of the instrument or in a separate writing signed by the recipients' officer or other person authorized to bind the recipient. They would also be required to collect and maintain certifications by sub-recipients who receive Department funds through them.

The proposed regulation would require that entities certify in writing that they will operate in compliance with the Church Amendments, PHS Act§ 245, and the Weldon Amendment as applicable. Certification provides a demonstrable way of ensuring that the recipients of such funding know of, and attest that they will comply with, the applicable nondiscrimination provisions.

Sub-recipients of federal funds-entities that will receive federal funds indirectly through another entity (a recipient or other sub-recipient)-would be required to provide certification as set out in the ''Subrecipient'' subsection of the' 'Certification of Compliance'' section, and submit them to the recipients through which they receive Department funds for maintenance.

Although it would be collected and maintained by the recipient, this certification by subrecipients would be a certification addressed to the Department, not to the recipients collecting the certification. Recipients would be expected to comply with requirements for retention of and access to records set forth in 45 CFR74.53.

While all recipients and subrecipients of Department funds are required to comply with the Church Amendments, PHS Act § 245, and the Weldon Amendment, as applicable, section 88.5(e), as proposed, would contain several important exceptions to the proposed requirement to provide the written certification, including individual physicians, physician offices, other health care practitioners, and other participants in Part B of the Medicare program; (2) physicians, physician offices, or other health care practitioners participating in Part C of the Medicare program, when such individuals or organizations are subrecipients of Department funds through a Medicare Advantage plan; and (3) subrecipients of State Medicaid programs (i.e., any entity that is paid for services by the State Medicaid program).

While other providers participating in the Medicare program as well as State Medicaid programs would be required to submit written certification of compliance to the Department, the large number of entities included in the categories of providers listed above (e.g., individual physicians, physician offices, other health care practitioners, and subrecipients of State Medicaid programs) would have posed significant implementation hurdles for Departmental components and programs. Furthermore, the Department believed that, due primarily to their generally smaller size, the excepted categories of recipients and subrecipients of Department funds in the above categories would be less likely to encounter the types of issues sought to be addressed in this regulation.

However, we noted in the proposed rule that excepted providers may become subject to the proposed written certification requirement by receiving Department funds under a separate agency or program. For example, under the proposed rule, a physician office participating in Medicare Part B may become subject to the proposed written certification requirement by receiving Department funds to conduct clinical research. We noted, however, that the State Medicaid programs would be responsible for ensuring the compliance of their sub-recipients as part of ensuring that the State Medicaid program is operated consistent with applicable nondiscrimination provisions.

Final Rule: Partly in Response to suggestions received in Response to solicitation of public Comment on this issue (see the Department Responses to the Comments on the proposed certification requirement above), HHS has determined to make further exceptions to the certification requirements in section 88.5 in the final rule.

Exceptions from the written certification requirement are included for Departmental grant programs whose purpose is unrelated to health care provision, including economic assistance, and which do not involve medical research or the involvement of health care providers, and which are unlikely to involve referral for provision of health care. These programs often involve funding to States and other governments for non-health care purposes, and/or cash assistance or vouchers, rather than direct services by a funded entity, to individuals. These programs are unlikely to involve Department funds being used for medical research, the participation of health care providers or referral to health care providers. As a consequence, these programs are also unlikely to encounter the circumstances contemplated by this regulation, and therefore the assurance of compliance represented by a certification is not considered necessary by the Department for such programs.

Programs excepted under this provision include certain current programs administered by the Administration for Children and Families, including Low-Income Home Energy Assistance Program, Assets for Independence, the Child Care and Development Fund, Job Opportunities for Low-Income Individuals, Mentoring Children of Prisoners, and programs overseen by the Office of Child Support Enforcement, as well as certain current programs administered by the Administration on Aging. Finally, an exception to the written certification requirement of section 88.5 has been included for Indian Tribes and Tribal Organizations when contracting with the Indian Health Service under the Indian Self-Determination and Education Assistance Act.

As stated in the proposed rule, individual Department components have been tasked with determining how best to implement the written certification requirements set out in this regulation in a way that ensures efficient program operation. To this end, Department components have been given discretion to phase in the written certification requirement by no later than the beginning of the next federal fiscal year following the effective date of the regulation.

Finally, we have reorganized the wording of the written certifications in section 88.5 for purposes of clarity and to more closely track the language of the health care conscience protection laws. Recipients are expected to comply with the records retention and access requirements in 45 CFR 74.53, 45 CFR92.42, 45 CFR 96.30, and any other applicable requirements.

Section 88.6 Complaint Handling and Investigating

Proposed Rule: This section did not appear in the proposed rule.

Final Rule: We have included a new section 88.6 to clarify, as was stated in the preamble to the proposed rule, that the HHS Office for Civil Rights (OCR) has been designated to receive complaints of discrimination and coercion based on the health care conscience protection statutes and this regulation. OCR will coordinate handling of complaints with the staff of the Departmental programs from which the entity, with respect to which a complaint has been filed, receives funding (i.e., Department funding component).


V.    Analysis of Economic Impacts

Executive Order 12866-Regulatory Planning and Review

HHS has examined the economic implications of this final rule as required by Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. HHS has determined that, although this final rule is not economically significant, it is a significant regulatory action as defined by Executive Order 12866.


[Inadequate Cost/Benefit Analysis]

Comment: One Comment stated that HHS did not provide an adequate cost benefit analysis as required by E.O.12866. The Comment pointed out that the Department concluded that the rule is a significant regulatory action but did not undertake a more formal analysis.

Response: HHS disagrees.

Our conclusion, based on the analysis of impacts of the proposed rule, was that the rule was not economically significant. Therefore, the assessment of potential costs and benefits provided was sufficient to meet the requirements of the Executive Order.

Comment: Two Comments stated HHS's analysis was inadequate in that it did not consider the costs of additional health care or other impacts on patients and employers because various definitions had been broadened.

Another Comment stated that HHS did not asses the effects on public health resulting from a decrease in access to care.

Response: HHS disagrees.

As stated previously, the Department does not agree that the interpretation of the terms used in this rule have been broadened or that the scope of the laws were expanded. Nor does HHS agree that this rule would cause changes in staffing or other processes beyond those changes entities have already incurred in order to comply with existing statutes.

This final rule does not limit patient access to health care, but rather implements existing federal laws. Thus, we have not changed our analysis in Response to this Comment.

An underlying assumption of this regulation is that the health care industry, including entities receiving Department funds, will benefit from more diverse and inclusive work forces by informing health care workers of their rights and fostering an environment in which individuals from many different faiths and philosophical backgrounds are encouraged to participate. As a result, we cannot accurately account for all of the regulation's future benefits, but the Department is confident that the future benefits will exceed the costs of complying with the regulation.

Comment: One Comment suggested that the number of affected entities suggests that the benefits will not exceed the costs of complying with the regulation. The Commenter provided no clarification and no data to support this statement.

Response: The Department has not revised its analysis in Response to this Comment. The statutes mandating the requirements for protecting health care workers as discussed in this rule have been in effect for a number of years. Therefore, the regulatory burden associated with this rule is largely associated with the incremental costs of certifying to the Federal government and the cost of collecting and maintaining records of certification statements from sub-recipients. We entities that would be required to certify to be 571,947 (see Table I).[7]

This estimate has been revised from the proposal to reflect new exceptions to the certification requirement for recipients of ACF, AOA, and IHS funds. We do not distinguish between recipients and subrecipients of HHS funding. Each entity could be a recipient, a sub-recipient, or both.

The Department envisions three subcategories of potential costs for recipients and sub-recipients of Department funds: (1) Direct costs associated with the act of certification;(2) Direct costs associated with collecting and maintaining certifications made by sub-recipients; and (3) indirect costs associated with certification.

In the analysis to the proposed rule, we explained that indirect costs associated with the certification requirement might include costs for such actions as staffing/scheduling changes and internal reviews to assess compliance. We further explained that there is insufficient data to estimate the number of funding recipients not currently compliant with the Church Amendments, PHS Act § 245, or the Weldon Amendment.

We received no Comments indicating that there were any funding recipients not currently compliant. Therefore, we continue to assume that, because together these three federal statutes have been inexistence for many years, the incremental indirect costs of certification will be minimal for Department funding recipients.

Comment: Four Commenters argued against our administrative cost estimates associated with the certification process. These Comments stated that the analysis of the proposed rule did not sufficiently account for the cost of collecting, maintaining, and submitting written certifications. However, the Comments provided no new information or data.

Response: HHS disagrees. In determining the costs associated with collecting and maintaining the certification, we reviewed the analysis and regulatory costs associated with or conducted for several other similar certification requirements for HHS programs. The Comments did not provide any new information or data nor did they suggest any activities for which we did not already account in the analysis. Thus, we have not changed the analysis in Response to these Comments.

The direct cost of certification is the cost of reviewing the certification language, reviewing relevant entity policies and procedures, and reviewing files before signing. We estimate that each of the 571,947 entities will spend an average of 30 minutes on these activities. Although some entities may need to sign a certification statement more than once, we assume that the entity will only carefully review the language, procedures and their files before signing the initial statement each year. We assume the cost of signing subsequent statements to be small.

Some existing HHS certification forms specify the certification statement should be signed by the CEO, CFO, direct owner, or Chairman of the Board. According to Bureau of Labor Statistics wage data, the mean hourly wage for occupation code 11-1011, Chief Executives, is $72.77. We estimate the loaded rate to be $145.54. Thus, the cost associated with the act of certification is $41.6 million (571,947 × .5 × $145.54).The direct cost of collecting and maintaining certifications made by subrecipients is estimated as the labor cost. We assume that each of the 63,741 grant awardees and 4,245 contractors doing business with HHS have at least one sub-recipient. We also assume that, on average, each grant awardee and contractor will spend one hour collecting and maintaining certifications made by sub-recipients. The mean hourly wage for office and administrative support occupations, occupation code 43-0000, is $15.00, or $30 loaded. Thus the cost of collecting and maintaining records is estimated to be $2 million (67,986 entities × 1 hour× $30).

Comment: One Comment suggested the analysis should consider the legal fees likely to flow from litigation over the proposed regulations.

Response: HHS disagrees. In assessing the costs and benefits of regulations, the government assumes compliance. Thus, the amount of litigation is assumed to be minimal and very difficult to predict. The total quantifiable costs of the regulation are estimated to be $43.6million each year.


Congressional Review Act

The Congressional Review Act defines a ''major rule'' as ''any rule that the Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget finds has resulted in or is likely to result in-(A) an annual effect on the economy of $100,000,000 or more; (B) a major increase in costs or prices for consumers, individual industries, federal, State, or local government agencies, or geographic regions; or (C)significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign based enterprises in domestic and export markets.'' 5 U.S.C. 804(2).

Based on OMB's review of the rule under Executive Order 12866, the Administrator of OIRA has determined that this rule is not a major rule for purposes of the Congressional Review Act. This finding of the Administrator is not subject to judicial review. 5 U.S.C.805.


Regulatory Flexibility Act

HHS has examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. This will not impose significant costs on small entities. Therefore, the Secretary certifies that this rule will not result in a significant impact on a substantial number of small entities.

Comment: One Comment suggested HHS should assess the impact on small entities who will incur costs to hire new staff and make staffing changes to accommodate objections by workforce members.

Response: HHS acknowledges that there may be indirect costs associated with the certification requirement including costs for such actions as staffing/scheduling changes and internal reviews to assess compliance. As stated in the proposed rule, there continues to be insufficient data to estimate the number of funding recipients not currently compliant with the Church Amendments, PHS Act § 245, or the Weldon Amendment. Because together these three federal statutes have been inexistence for many years, we expect the incremental and indirect costs of certification to be minimal for Department funding recipients. HHS received no Comments on this assumption. Therefore, we continue to conclude that these indirect costs of certification will be minimal.


Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4)requires cost-benefit and other analyses before any rulemaking if the rule would include a ''Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.'' The current inflation adjusted statutory threshold is about$115 million. HHS has determined that this final rule would not constitute a significant rule under the Unfunded Mandates Reform Act.


Federalism

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on state and local governments, preempts State law, or otherwise has federalism implications.

All three statutes implemented through this regulation-the Church Amendments, PHS Act § 245, and the Weldon Amendment-impose restrictions on States, local governments, and public entities receiving funds from the Department, including under certain Department implemented statutes. Insofar as these regulations impact State and local governments in addition to those impacts caused by the statutoryprovisions, they do so only to the extent that States and local governments are required to submit certifications of compliance with the statutes and this regulation, as applicable.

Since we expect the recipients of Department funds to comply with existing federal law, we anticipate the impact on States and local governments of the certification requirement to be negligible. The Department received Comments from a number of States, State officials, or components of State governments on the proposed rule. The Department considered those Comments in finalizing the rule.


Assessment of Federal Regulation and Policies on Families

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires federal departments and agencies to determine whether a proposed policy or regulation could affect family well-being. If the determination is affirmative, then the Department or agency must prepare an impact assessment to address criteria specified in the law.

Comment: Several Comments disagreed with the Department's assertion in the proposed rule that the regulation will not have an impact on family well-being. Another Commenter stated that the Treasury and General Government Appropriations Act of 1999 requires the Department to determine if the proposed rule would affect family well-being. The Commenter stated that if family well-being is affected, the Department must provide an impact assessment of these effects. The Commenter also stated that the proposed rule does not adequately address the impact on family well being.

Response: The Department disagrees.

This final rule defines certain key terms, ensures that recipients of Department funds know about their legal obligations under existing federal health care provider conscience protection provisions, and requires written certification by certain recipients that they will comply with such provisions, as applicable. As stated above, the rule does not expand the scope of existing federal health care conscience protection laws, nor does it create new barriers to health care access that might have an impact on family well-being. The Department finds that this rule does not affect family well-being within the meaning of meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (Pub. L. 105-277, 112 Stat. 2681).


VI.    Paperwork Reduction Act of 1995

HHS received Comments on the burden associated with the written certification requirements contained in sections 88.5(a), (c) and (d) of this final rule and are therefore soliciting Comments on the information collection requirements associated with this rule, consistent with the Paperwork Reduction Act of 1995.

To obtain or retain federal funding for various activities, the Department requires the certification of all recipients and sub-recipients of Department funding. The certification and associated documents are necessary to ensure that recipients and subrecipients of federal funds comply with federal anti-discrimination law.

Likely respondents to this certification requirement include all entities required to certify as estimated in the EO 12866 analysis listed above, which provides a high estimate of571,947 recipients and sub-recipients. As outlined above, it will take an estimated 30 minutes for each recipient and sub-recipient to review the relevant language and provide the relevant certifications as well as, in the case of recipients, to collect and maintain certifications by sub-recipients, as applicable.

The Department therefore estimates the annual aggregate burden to collect the information to be as follows:

  • The Department is seeking public Comments on the proposed data collection associated with this final rule through a 60-day Federal Register notice. Interested persons are invited to send Comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
    • (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
    • (2) the accuracy of the estimated burden;
    • (3) ways to enhance the quality, utility, and clarity of the information to be collected; and
    • (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. This final rule becomes effective 30 days after publication. However, affected parties do not have to comply with the information collection requirements in the final rule until the Department of Health and Human Services publishes in the Federal Register the control numbers assigned by the Office of Management and Budget (OMB). Publication of the control numbers notifies the public that OMB has approved these information collection requirements under the Paperwork Reduction Act of 1995.