Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules 10207 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

§ 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this proposed rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Lacosamide products will be 

prescription drugs used for the 

treatment of partial-onset seizures. 

Handlers of lacosamide often handle 

other controlled substances used in the 

treatment of central nervous system 

disorders which are already subject to 

the regulatory requirements of the CSA. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in §§ 3(a) and 3(b)(2) 

of Executive Order 12988 Civil Justice 

Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law; nor 

does it impose enforcement 

responsibilities on any state; nor does it 

diminish the power of any state to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

provisions of the Unfunded Mandates 

Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act). This 

rule will not result in an annual effect 

on the economy of $100,000,000 or 

more; a major increase in costs or prices: 

or significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

Under the authority vested in the 

Attorney General by § 201(a) of the CSA 

(21 U.S.C. 811(a)), and delegated to the 

Administrator of DEA by Department of 

Justice regulations (28 CFR 0.100), and 

redelegated to the Deputy Administrator 

pursuant to 28 CFR 0.104, the Deputy 

Administrator hereby proposes that 21 

CFR part 1308 be amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

2. Section 1308.15 is amended by 

revising paragraph (e)(1) adding a new 

paragraph (e)(2) to read as follows: 

§ 1308.15 Schedule V. 

* * * * * 

(e) * * * 

(1) Lacosamide [(R)-2-acetoamido-Nbenzyl-3-methoxy-propionamide]—2746 

(2) Pregabalin [(S)-3-(aminomethyl)-5- 

methylhexanoic acid]—2782 

Dated: February 26, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–4890 Filed 3–9–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 88 

RIN 0991–AB49 

Rescission of the Regulation Entitled 

‘‘Ensuring That Department of Health 

and Human Services Funds Do Not 

Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law’’; Proposal 

AGENCY: Office of the Secretary, HHS. 

ACTION: Proposed rule. 

SUMMARY: The Department of Health and 

Human Services proposes to rescind the 

December 19, 2008 final rule entitled 

‘‘Ensuring That Department of Health 

and Human Services Funds Do Not 

Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law.’’ The Department believes 

it is important to have an opportunity to 

review this regulation to ensure its 

consistency with current 

Administration policy and to reevaluate 

the necessity for regulations 

implementing the Church Amendments, 

Section 245 of the Public Health Service 

Act, and the Weldon Amendment. 

DATES: Submit written or electronic 

comment on the regulatory changes 

proposed by this document by April 9, 

2009. 

ADDRESSES: In commenting, please refer 

to ‘‘Rescission Proposal.’’ To better 

manage the comment process, we will 

not accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.Regulations.gov or via email to proposedrescission@hhs.gov. To 

submit electronic comments to http:// 

www.Regulations.gov, go to the Web site 

and click on the link ‘‘Comment or 

Submission’’ and enter the keywords 

‘‘Rescission Proposal.’’ [Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.] 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address only: 

Office of Public Health and Science, 

Department of Health and Human 

Services, Attention: Rescission Proposal 

Comments, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Room 716G, Washington, DC 

20201. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address only: Office of Public Health 

and Science, Department of Health and 

Human Services, Attention: Rescission 

Proposal Comments, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Room 716G, Washington, 

DC 20201. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to the following 

address: Room 716G, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the mail drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain proof of 

filing by stamping in and retaining an 

extra copy of the documents being 

filed.) 

Inspection of Public Comments: All 

comments received before the close of 

10208 Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.Regulations.gov. Click on the link 

‘‘Comment or Submission’’ on that Web 

site to view public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Department of Health and Human 

Services, Hubert H. Humphrey Building, 

200 Independence Avenue, SW., 

Washington, DC 20201, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. 

Electronic Access 

This Federal Register document is 

also available from the Federal Register 

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. Free public access is available on 

a Wide Area Information Service 

(WAIS) through the Internet and via 

asynchronous dial-in. Internet users can 

access the database by using the World 

Wide Web (the Superintendent of 

Documents’ home page address is 

http://www.gpoaccess.gov/), by using 

local WAIS client software, or by telnet 

to swais.access.gpo.gov, then login as 

guest (no password required). Dial-in 

users should use communications 

software and modem to call (202) 512– 

1661; type swais, then login as guest (no 

password required). 

FOR FURTHER INFORMATION CONTACT: 

Mahak Nayyar, (240) 276–9866, Office 

of Public Health and Science, 

Department of Health and Human 

Services, Room 716G, Hubert E. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Statutory Background 

Several provisions of federal law 

prohibit recipients of certain federal 

funds from coercing individuals in the 

health care field into participating in 

actions they find religiously or morally 

objectionable. 

Conscience Clauses/Church 

Amendments [42 U.S.C. 300a–7] 

The conscience provisions contained 

in 42 U.S.C. 300a–7 (collectively known 

as the ‘‘Church Amendments’’) were 

enacted at various times during the 

1970s in response to debates over 

whether receipt of federal funds 

required the recipients of such funds to 

perform abortions or sterilizations. The 

first conscience provision in the Church 

Amendments, 42 U.S.C. 300a–7(b), 

provides that ‘‘[t]he receipt of any grant, 

contract, loan, or loan guarantee under 

[certain statutes implemented by the 

Department of Health and Human 

Services] by any individual or entity 

does not authorize any court or any 

public official or other public authority 

to require’’ (1) The individual to 

perform or assist in a sterilization 

procedure or an abortion, if it would be 

contrary to his/her religious beliefs or 

moral convictions; (2) the entity to make 

its facilities available for sterilization 

procedures or abortions, if the 

performance of sterilization procedures 

or abortions in the facilities is 

prohibited by the entity on the basis of 

religious beliefs or moral convictions; or 

(3) the entity to provide personnel for 

the performance or assistance in the 

performance of sterilization procedures 

or abortions, if it would be contrary to 

the religious beliefs or moral 

convictions of such personnel. 

The second conscience provision in 

the Church Amendments, 42 U.S.C. 

300a–7(c)(1), prohibits any entity that 

receives a grant, contract, loan, or loan 

guarantee under certain Departmentimplemented statutes from 

discriminating against any physician or 

other health care personnel in 

employment, promotion, termination of 

employment, or the extension of staff or 

other privileges because the individual 

‘‘performed or assisted in the 

performance of a lawful sterilization 

procedure or abortion, because he 

refused to perform or assist in the 

performance of such a procedure or 

abortion on the grounds that his 

performance or assistance in the 

performance of the procedure or 

abortion would be contrary to his 

religious beliefs or moral convictions, or 

because of his religious beliefs or moral 

convictions respecting sterilization 

procedures or abortions.’’ 

The third conscience provision, 

contained in 42 U.S.C. 300a–7(c)(2), 

prohibits any entity that receives a grant 

or contract for biomedical or behavioral 

research under any program 

administered by the Department from 

discriminating against any physician or 

other health care personnel in 

employment, promotion, termination of 

employment, or extension of staff or 

other privileges ‘‘because he performed 

or assisted in the performance of any 

lawful health service or research 

activity, because he refused to perform 

or assist in the performance of any such 

service or activity on the grounds that 

his performance or assistance in the 

performance of such service or activity 

would be contrary to his religious 

beliefs or moral convictions, or because 

of his religious beliefs or moral 

convictions respecting any such service 

or activity.’’ 

The fourth conscience provision, 42 

U.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 

Department] 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.’’ 

The final conscience provision 

contained in the Church Amendments, 

42 U.S.C. 300a–7(e), prohibits any entity 

that receives a grant, contract, loan, loan 

guarantee, or interest subsidy under 

certain Departmentally implemented 

statutes from denying admission to, or 

otherwise discriminating against, ‘‘any 

applicant (including applicants for 

internships and residencies) for training 

or study because of the applicant’s 

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.’’ 

Public Health Service Act Sec. 245 [42 

U.S.C. 238n] 

Enacted in 1996, section 245 of the 

Public Health Service Act (PHS Act) 

prohibits the federal government and 

any State or local government receiving 

federal financial assistance from 

discriminating against any health care 

entity on the basis that the entity (1) 

‘‘Refuses to undergo training in the 

performance of induced abortions, to 

require or provide such training, to 

perform such abortions, or to provide 

referrals for such training or such 

abortions;’’ (2) refuses to make 

arrangements for such activities; or (3) 

‘‘attends (or attended) a post-graduate 

physician training program, or any other 

program of training in the health 

professions, that does not (or did not) 

perform induced abortions or require, 

provide, or refer for training in the 

performance of induced abortions, or 

make arrangements for the provision of 

such training.’’ For the purposes of this 

protection, the statute defines ‘‘financial 

assistance’’ as including, ‘‘with respect 

to a government program,’’ 

‘‘governmental payments provided as 

reimbursement for carrying out healthrelated activities.’’ In addition, PHS Act 

Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules 10209 

Sec. 245 requires that, in determining 

whether to grant legal status to a health 

care entity (including a State’s 

determination of whether to issue a 

license or certificate), the federal 

government and any State or local 

government receiving federal financial 

assistance shall deem accredited any 

post-graduate physician training 

program that would be accredited, but 

for the reliance on an accrediting 

standard that, regardless of whether 

such standard provides exceptions or 

exemptions, requires an entity: (1) to 

perform induced abortions; or (2) to 

require, provide, or refer for training in 

the performance of induced abortions, 

or make arrangements for such training. 

Weldon Amendment 

The Weldon Amendment, originally 

adopted as section 508(d) of the LaborHHS Division (Division F) of the 2005 

Consolidated Appropriations Act, 

Public Law 108–447, 118 Stat. 2809, 

3163 (Dec. 8, 2004), has been readopted 

(or incorporated by reference) in each 

subsequent HHS appropriations act. 

Title V of the Departments of Labor, 

Health and Human Services, and 

Education, and Related Agencies 

Appropriations Act, 2006, Public Law 

109–149, Sec. 508(d), 119 Stat. 2833, 

2879–80 (Dec. 30, 2005); Revised 

Continuing Appropriations Resolution 

of 2007, Public Law 110–5, Sec. 2, 121 

Stat. 8, 9 (Feb. 15, 2007); Consolidated 

Appropriations Act, 2008, Public Law 

110–161, Div. G, Sec. 508(d), 121 Stat. 

1844, 2209 (Dec. 26, 2007); 

Consolidated Security, Disaster 

Assistance, and Continuing 

Appropriations Act, 2009, Public Law 

110–329, Div. A, Sec. 101, 122 Stat. 

3574, 3575 (Sept. 30, 2008). The Weldon 

Amendment provides that ‘‘[n]one of 

the funds made available in this Act 

[making appropriations for the 

Departments of Labor, Health and 

Human Services, and Education] may be 

made available to a Federal agency or 

program, or to a State or local 

government, 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.’’ It also defines ‘‘health care 

entity’’ to include ‘‘an individual 

physician or other health care 

professional, a hospital, a providersponsored organization, a health 

maintenance organization, a health 

insurance plan, or any other kind of 

health care facility, organization, or 

plan.’’ 

Rulemaking 

No statutory provision requires the 

promulgation of rules to implement the 

requirements of the Church 

Amendments, Public Health Service 

(PHS) Act Sec. 245, and the Weldon 

Amendment. Nevertheless, on August 

26, 2008, the Department exercised its 

discretion and issued a proposed rule 

entitled ‘‘Ensuring that Department of 

Health and Human Services Funds Do 

Not Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law’’ (73 FR 50274). Citing 

concerns that the development of an 

environment in the health care field that 

is intolerant of individual conscience, 

certain religious beliefs, ethnic and 

cultural traditions, and moral 

convictions may discourage individuals 

from diverse backgrounds from entering 

health care professions, the Department 

concluded that regulations were 

necessary in order to (1) Educate the 

public and health care providers on the 

obligations imposed, and protections 

afforded, by federal law; (2) work with 

State and local governments and other 

recipients of funds from the Department 

to ensure compliance with the 

nondiscrimination requirements 

embodied in the Church Amendments, 

PHS Act Sec. 245, and the Weldon 

Amendment; (3) when such compliance 

efforts prove unsuccessful, enforce these 

nondiscrimination laws through the 

various Department mechanisms, to 

ensure that Department funds do not 

support coercive or discriminatory 

practices, or policies in violation of 

federal law; and (4) otherwise take an 

active role in promoting open 

communication within the healthcare 

industry, and between providers and 

patients, fostering a more inclusive, 

tolerant environment in the health care 

industry than may currently exist. 

A wide variety of individuals and 

organizations, including private 

citizens, individual and institutional 

health care providers, religious 

organizations, patient advocacy groups, 

professional organizations, universities 

and research institutions, consumer 

organizations, and State and federal 

agencies and representatives, 

commented on the proposed rule. 

Comments dealt with a range of issues 

surrounding the proposed rule, 

including the need for the rule, what 

kinds of workers would be protected by 

the proposed rule, the rule’s 

relationship to Title VII of the Civil 

Rights Act and other statutes and 

protections, what services are covered 

by the rule, whether health care workers 

might use the regulation to discriminate 

against patients, what significant 

implementation issues could be 

associated with the rule, legal 

arguments, the cost impacts and the 

public health consequences of the rule. 

On December 19, 2008, the 

Department issued a final rule (73 FR 

78072). The Department saw a need to 

balance the rights of patients in 

obtaining legal health care services 

against the statutory rights of providers 

in the context of federally funded 

entities not to be discriminated against 

based on a refusal to participate in a 

service to which they have objections. 

Thus, the Department imposed an 

additional certification requirement by 

specifically including a reference to the 

nondiscrimination provisions contained 

in the Church Amendments, PHS Act 

Sec. 245, and the Weldon Amendment 

in certifications currently required of 

most existing and potential recipients of 

Department funds. The final rule went 

into effect on January 20, 2009, except 

that 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. Furthermore, the 

certification requirement is not effective 

pending completion of the information 

collection process under the Paperwork 

Reduction Act. The 60-day comment 

period on the information collection 

expired on February 27, 2009, and OMB 

approval for the information collection 

has not yet been sought. 

II. Proposed Rule 

The Department is proposing to 

rescind in its entirety the final rule 

entitled ‘‘Ensuring That Department of 

Health and Human Services Funds Do 

Not Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law,’’ published in the Federal 

Register on December 19, 2008 (73 FR 

78072, 45 CFR Part 88). Commenters 

asserted that the rule would limit access 

to patient care and raised concerns that 

individuals could be denied access to 

services, with effects felt 

disproportionately by those in rural 

areas or otherwise underserved. The 

Department believes that the comments 

on the August 2008 proposed rule raised 

a number of questions that warrant 

further careful consideration. It is 

important that the Department have the 

opportunity to review this regulation to 

ensure its consistency with current 

Administration policy. Accordingly, we 

believe it would benefit the Department 

to review this rule, accept further 

comments, and reevaluate the necessity 

for regulations implementing the 

statutory requirements. Thus, the 

Department is proposing to rescind the 

10210 Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules 

December 19, 2008 final rule, and we 

are soliciting public comment to aid our 

consideration of the many complex 

questions surrounding the issue and the 

need for regulation in this area. 

III. Statutory Authority 

The Secretary proposes to rescind the 

December 19, 2008 final rule entitled 

‘‘Ensuring That Department of Health 

and Human Services Funds Do Not 

Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law.’’ As discussed above, the 

Church Amendments, section 245 of the 

PHS Act, and the Weldon Amendment 

require, among other things, that the 

Department and recipients of 

Department funds (including State and 

local governments) refrain from 

discriminating against institutional and 

individual health care entities for their 

participation in certain medical 

procedures or services, including 

certain health services, or research 

activities funded in whole or in part by 

the federal government. No statutory 

provision, however, requires 

promulgation of a rule such as that 

published on December 19, 2008. This 

proposed rule is being issued pursuant 

to the authority of 5 U.S.C. 301, which 

empowers the head of an Executive 

department to prescribe regulations ‘‘for 

the government of his department, the 

conduct of his employees, the 

distribution and performance of its 

business, and the custody, use, and 

preservation of its records, papers, and 

property.’’ 

IV. Request for Comment 

The Department, in order to 

determine whether or not to rescind the 

final rule in part or in its entirety, seeks 

comments. In particular, the Department 

seeks the following: 

1. Information, including specific 

examples where feasible, addressing the 

scope and nature of the problems giving 

rise to the need for federal rulemaking 

and how the current rule would resolve 

those problems; 

2. Information, including specific 

examples where feasible, supporting or 

refuting allegations that the December 

19, 2008 final rule reduces access to 

information and health care services, 

particularly by low-income women; 

3. Comment on whether the December 

19, 2008 final rule provides sufficient 

clarity to minimize the potential for 

harm resulting from any ambiguity and 

confusion that may exist because of the 

rule; and 

4. Comment on whether the objectives 

of the December 19, 2008 final rule 

might also be accomplished through 

non-regulatory means, such as outreach 

and education. 

V. Impact Analysis 

Executive Order 12866—Regulatory 

Planning and Review 

HHS has examined the economic 

implications of this proposed 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 single sector of the economy 

in a material way, adversely affecting 

competition, or adversely affecting jobs. 

This proposed rule is not significant 

under these economic standards. 

However, under Executive Order 12866, 

a regulation is also considered a 

significant regulatory action if it raises 

novel legal or policy issues. Because 

HHS previously determined that the 

December 19, 2008 final rule was a 

significant regulatory action under this 

standard, HHS will assume that the 

proposed rescission of the December 19, 

2008 final rule is also a significant 

regulatory action. 

The December 19, 2008 final rule 

estimated the quantifiable costs 

associated with the certification 

requirements of the proposed regulation 

to be $43.6 million each year. 

Rescinding the rule would therefore 

result in a cost savings of $43.6 million 

each year to the health care industry. 

Regulatory Flexibility Act 

HHS has examined the economic 

implications of this proposed rule as 

required by the Regulatory Flexibility 

Act (RFA). If a rule has a significant 

economic burden on a substantial 

number of small entities, the RFA 

requires agencies to analyze regulatory 

options that would lessen the economic 

effect of the rule on small entities. For 

purposes of the RFA, small entities 

include small businesses, nonprofit 

organizations, and small governmental 

jurisdictions. Most hospitals and most 

other providers and suppliers are small 

entities by virtue of either nonprofit 

status or having revenues of $6 million 

to $29 million in any 1 year. Individuals 

and States are not included in the 

definition of a small entity. The position 

of the Department has long been that the 

RFA requirements for regulatory 

flexibility analysis only apply to rules 

that create significant adverse impacts 

on small entities. Rescission of the final 

rule may create positive impacts on 

small entities by removing any burdens 

imposed by that rule. Accordingly, we 

certify that this proposed rule will not 

have a significant effect on a substantial 

number of small entities. 

Executive Order 13132—Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on state and local 

governments, preempts State law, or 

otherwise has federalism implications. 

This proposed rule would not require 

additional steps to meet the 

requirements of Executive Order 13132 

because it removes any burden imposed 

by the December 19, 2008 final rule. 

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 analysis 

before any rulemaking if the rule 

includes 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 inflationadjusted statutory threshold is 

approximately $130 million. The 

Department has determined that this 

proposed rule would not constitute a 

significant rule under the Unfunded 

Mandates Reform Act, because it would 

rescind rather than impose mandates. 

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. This regulation 

will not have an impact on family wellbeing, as defined in the Act, because it 

affects only regulated entities and 

eliminates costs that would otherwise 

be imposed on those entities. 

Paperwork Reduction Act of 1995 

This proposed rule does not create 

any new requirements under the 

Paperwork Reduction Act of 1995. 

Instead, it proposes to eliminate 

Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules 10211 

requirements that would be imposed by 

the final rule issued on December 19, 

2008. The 60-day comment period on 

the information collection requirements 

of the December 19, 2008 final rule 

expired on February 27, 2009, and OMB 

approval for the information collection 

requirements has not yet been sought. 

List of Subjects in 45 CFR Part 88 

Abortion, Civil rights, Colleges and 

universities, Employment, Government 

contracts, Government employees, Grant 

programs, Grants administration, Health 

care, Health insurance, Health 

professions, Hospitals, Insurance 

companies, Laboratories, Medicaid, 

Medical and dental schools, Medical 

research, Medicare, Mental health 

programs, Nursing homes, Public 

health, Religious discrimination, 

Religious liberties, Reporting and 

recordkeeping requirements, Rights of 

conscience, Scientists, State and local 

governments, Sterilization, Students. 

Dated: March 5, 2009. 

Charles E. Johnson, 

Acting Secretary. 

PART 88—[REMOVED AND 

RESERVED] 

Therefore, under 5 U.S.C. 301, the 

Department of Health and Human 

Services proposes to remove and reserve 

45 CFR part 88. 

[FR Doc. E9–5067 Filed 3–6–09; 11:15 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[FWS–R8–ES–2008–0078; 92210–1117– 

0000–B4] 

RIN 1018–AV03 

Endangered and Threatened Wildlife 

and Plants; Designation of Critical 

Habitat for Cirsium loncholepis (La 

Graciosa thistle) 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; reopening of 

comment period, notice of availability 

of draft economic analysis, and 

amended required determinations. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce the 

reopening of the comment period on the 

proposed revised designation of critical 

habitat for Cirsium loncholepis 

(common name La Graciosa thistle) 

under the Endangered Species Act of 

1973, as amended (Act). We also 

announce the availability of the January 

16, 2009, draft economic analysis (DEA) 

of the proposed revised designation of 

critical habitat for C. loncholepis and 

announce an amended required 

determinations section of the proposal. 

We are reopening the comment period 

to allow all interested parties an 

opportunity to comment simultaneously 

on the proposed revised designation of 

critical habitat for C. loncholepis, the 

associated DEA, and the amended 

required determinations section. 

Comments previously submitted on this 

rulemaking do not need to be 

resubmitted. These comments have 

already been incorporated into the 

public record and will be fully 

considered in preparation of the final 

rule. 

DATES: We will accept public comments 

received or postmarked on or before 

April 9, 2009. 

ADDRESSES: You may submit comments 

by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• U.S. mail or hand-delivery: Public 

Comments Processing, Attn: RIN 1018– 

AV03; Division of Policy and Directives 

Management; U.S. Fish and Wildlife 

Service; 4401 N. Fairfax Drive, Suite 

222; Arlington, VA 22203. 

We will not accept e-mail or faxes. We 

will post all comments on http:// 

www.regulations.gov. This generally 

means that we will post any personal 

information you provide us (see the 

Public Comments section below for 

more information). 

FOR FURTHER INFORMATION CONTACT: 

Diane K. Noda, Field Supervisor, 

Ventura Fish and Wildlife Office, 2493 

Portola Road, Suite B, Ventura, CA 

93003, (telephone 805–644–1766; 

facsimile 805–644–3958). If you use a 

telecommunications device for the deaf 

(TDD), call the Federal Information 

Relay Service (FIRS) at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Public Comments 

We will accept written comments and 

information during this reopened 

comment period on the proposed 

revised designation of critical habitat for 

Cirsium loncholepis published in the 

Federal Register on August 6, 2008 (73 

FR 45805), the DEA of the proposed 

revised designation of critical habitat for 

Cirsium loncholepis, and the amended 

required determinations provided in 

this document. We will consider 

information and recommendations from 

all interested parties. We are 

particularly interested in comments 

concerning: 

1. The reasons why we should or 

should not designate habitat as critical 

habitat under section 4 of the Act (16 

U.S.C. 1533), including whether the 

benefit of designation would outweigh 

threats to the species caused by the 

designation, such that the designation of 

critical habitat is prudent. 

2. Specific information on: 

• The amount and distribution of 

Cirsium loncholepis habitat, 

• The importance of including habitat 

that provides connectivity between 

extant populations of Cirsium 

loncholepis to the species’ conservation 

and recovery, and the amount and 

distribution of such habitat, 

• What areas occupied at the time of 

listing and that contain features 

essential for the conservation of the 

species should be included in the 

designation and why, and 

• What areas not occupied at the time 

of listing are essential to the 

conservation of the species and why. 

3. Land use designations and current 

or planned activities in the subject areas 

and their possible impacts on proposed 

revised designation of critical habitat for 

Cirsium loncholepis. 

4. Probable economic, national 

security, or other impacts from 

designating particular areas as critical 

habitat. We are particularly interested in 

any impacts on small entities and 

specific impacts on national security, 

and the benefits of including or 

excluding areas that exhibit these 

impacts. 

5. Any proposed critical habitat areas 

covered by existing or proposed 

conservation or management plans that 

we should consider for exclusion from 

the designation under section 4(b)(2) of 

the Act. We specifically request 

information on any final or draft habitat 

conservation plans that include Cirsium 

loncholepis as a covered species that 

have been prepared under section 

10(a)(1)(B) of the Act, or any other 

management plan, conservation plan, or 

agreement that benefits this plant or its 

primary constituent elements. 

6. Land use designations and current 

or planned activities in the subject areas 

and their possible impacts on the 

proposed revised designation of critical 

habitat for Cirsium loncholepis. 

7. Additional scientific information 

that will help us to better delineate 

areas that contain the primary 

constituent elements. 

8. Any foreseeable environmental 

impacts directly or indirectly resulting 

from the proposed revised designation 

of critical habitat for Cirsium 

loncholepis.