This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

20091 

Vol. 79, No. 70 

Friday, April 11, 2014 

1For editorial reasons, upon codification in the 

U.S. Code, Part B was redesignated Part A. 

2For editorial reasons, upon codification in the 

U.S. Code, Part C was redesignated Part A–1. 

3All references to EPCA in this document refer 

to the statute as amended through the enactment of 

the AEMTCA. 

DEPARTMENT OF ENERGY 

10 CFR Part 430 

[Docket No. EERE–2013–BT–NOA–0047] 

RIN 1904–AD08 

Energy Conservation Program: Energy 

Conservation Standards for Certain 

Consumer Products 

AGENCY: Office of Energy Efficiency and 

Renewable Energy, Department of 

Energy. 

ACTION: Final rule. 

SUMMARY: The U.S. Department of 

Energy (DOE or the ‘‘Department’’) 

adopts into the Code of Federal 

Regulations the definitions for 

‘‘through-the-wall central air 

conditioner’’ and ‘‘through-the-wall 

central air conditioning heat pump’’ that 

were established in section 5 of the 

American Energy Manufacturing 

Technical Corrections Act. This 

document also removes the standards 

for air conditioners that were 

superseded effective in 2006, and the 

now defunct references to the ‘‘throughthe-wall air conditioner and heat pump’’ 

product class, including the definition 

and standards. 

DATES: The effective date of this rule is 

May 12, 2014. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Lucas Adin, U.S. Department of Energy, 

Office of Energy Efficiency and 

Renewable Energy, Building 

Technologies Program, EE–2J, 1000 

Independence Avenue SW., 

Washington, DC, 20585–0121, 202–287– 

1317, email: Lucas.Adin@ee.doe.gov. 

Jennifer Tiedeman, U.S. Department of 

Energy, Office of the General Counsel, 

GC–71, 1000 Independence Avenue 

SW., Washington, DC 20585–0121. 

Telephone: (202) 287–6111. email: 

Jennifer.Tiedeman@hq.doe.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background and Authority 

II. Discussion 

III. Procedural Requirements 

A. Review Under Executive Order 12866 

B. Review Under the Regulatory Flexibility 

Act 

C. Review Under the Paperwork Reduction 

Act of 1995 

D. Review Under the National 

Environmental Policy Act of 1969 

E. Review Under Executive Order 13132 

F. Review Under Executive Order 12988 

G. Review Under the Unfunded Mandates 

Reform Act of 1995 

H. Review Under the Treasury and General 

Government Appropriations Act, 1999 

I. Review Under Executive Order 12630 

J. Review Under the Treasury and General 

Government Appropriations Act, 2001 

K. Review Under Executive Order 13211 

L. Review Under Section 32 of the Federal 

Energy Administration Act of 1974 

IV. Approval of the Office of the Secretary 

I. Background and Authority 

The American Energy Manufacturing 

Technical Corrections Act (AEMTCA), 

Public Law 112–210, was signed into 

law on December 18, 2012. Among its 

provisions are amendments to Part B1 of 

Title III of the Energy Policy and 

Conservation Act of 1975 (EPCA or ‘‘the 

Act’’) (42 U.S.C. 6291–6309, as 

codified), which provides for an energy 

conservation program for consumer 

products other than automobiles, and to 

Part C2 of Title III of EPCA (42 U.S.C. 

6311–6317, as codified), which provides 

for an energy conservation program for 

certain commercial and industrial 

equipment, similar to the one in Part B 

for consumer products.3 Some of the 

AEMTCA amendments to EPCA 

establish or modify certain energy 

conservation standards and related 

definitions, and make technical changes 

to the Act. Other AEMTCA amendments 

to EPCA prescribe criteria for the 

conduct of rulemakings to promulgate 

energy conservation standards for 

various consumer products and 

commercial and industrial equipment, 

or direct the Department of Energy 

(DOE) to undertake rulemakings under 

EPCA. 

II. Discussion 

In today’s final rule, DOE is adopting 

several changes to its regulations 

regarding certain types of residential 

central air conditioners, which DOE 

proposed in a notice published on 

December 20, 2013. 78 FR 77019. 

Specifically, DOE proposed to amend 

the Code of Federal Regulations (CFR) to 

include the definitions for ‘‘through-thewall central air conditioner’’ and 

‘‘through-the-wall central air 

conditioning heat pump’’ that were 

prescribed by the AEMTCA. 42 U.S.C. 

6295(d)(4)(A)(ii). DOE proposed to 

amend the language of its regulations in 

10 CFR 430.2 to adopt these statutory 

definitions. Although the definitions for 

‘‘through-the-wall central air 

conditioner’’ and ‘‘through-the-wall 

central air conditioning heat pump’’ are 

new, these through-the-wall (‘‘TTW’’) 

products have been subject to standards 

since 2006. 

The December 20, 2013 proposed rule 

also included a proposal to remove a 

variety of provisions from 10 CFR 

430.32(c) that reference historical 

standards. Specifically, DOE proposed 

to remove paragraph (c)(1) which 

contains standards for certain products 

manufactured between 1992/1993 and 

2006. DOE also proposed to amend its 

regulations in 10 CFR 430.32(c)(2) and 

(c)(3) to remove references to the 

‘‘through-the-wall air conditioner and 

heat pump’’ product class, which 

applied to certain products 

manufactured prior to January 23, 2010. 

To avoid confusion with the new 

statutory definitions, DOE proposed to 

remove the ‘‘through-the-wall air 

conditioner and heat pump’’ product 

class definition currently in 10 CFR 

430.2. 

Although DOE is removing the 

outdated standards for the TTW product 

classes, DOE wants to be clear that the 

TTW products (for which this rule is 

adding definitions) are currently subject 

to standards. As discussed in a May 23, 

2002 final rule that adopted amended 

energy conservation standards for 

several classes of residential central air 

conditioners and heat pumps, DOE 

initially created a separate product class 

for TTW products. 67 FR 36368, 36397. 

DOE explained that it was adopting 

separate standards for TTW products 

based on its analysis of the design 

characteristics of these products. Id. 

However, DOE also identified a concern 

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20092 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 

that separate standards for TTW 

products could encourage purchasers of 

equipment covered by more stringent 

standards to shift to TTW products. To 

address this concern, DOE defined the 

TTW product class as applicable to 

products manufactured prior to January 

23, 2010, and specified that TTW 

products manufactured on or after that 

date would have to comply with the 

standard for other space-constrained 

products. 67 FR 36368, 36402. 

This definition was retained in the 

August 17, 2004 technical amendment 

that addressed the ruling of the U.S. 

Court of Appeals for the Second Circuit, 

which affected the standards for splitsystem and single-package central air 

conditioners but did not affect the 

standards for space-constrained and 

TTW products. 69 FR 50997, 50998. 

Thus, the 2004 rule again specified that 

the TTW standards applied to products 

manufactured prior to January 23, 2010, 

and that TTW products manufactured 

on or after that date would be subject to 

the space-constrained product class. 

The 2004 rule also included a footnote 

to the standards table in 10 CFR 

430.32(c)(2) to ensure that this 

limitation was clear. Id. Finally, in the 

June 27, 2011 direct final rule that 

amended the current energy efficiency 

standards for residential central air 

conditioners and heat pumps, DOE 

again affirmed the applicability of the 

TTW product class and amended the 

footnote to clarify the classification of 

TTW products. 76 FR 37408, 37446. 

Having received no public comments 

on the proposals in the December 20, 

2013 proposed rule, DOE is adopting the 

proposed changes described in this 

section. DOE notes that, while this final 

rule removes the references to the nowdefunct TTW product class standards, 

through-the-wall central air 

conditioners and through-the-wall 

central air conditioning heat pumps 

must be assigned to a product class 

based on the product’s characteristics. 

Product class definitions can be found 

in 10 CFR 430.2 and 10 CFR part 430, 

subpart B, appendix M. DOE believes 

that most, if not all, of the historicallycharacterized ‘‘through-the-wall’’ 

products will be assigned to one of the 

space-constrained product classes. 

III. Procedural Requirements 

A. Review Under Executive Order 12866 

Today’s regulatory action is not a 

‘‘significant regulatory action’’ under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, 58 FR 

51735 (Oct. 4, 1993). Accordingly, this 

action was not subject to review under 

that Executive Order by the Office of 

Information and Regulatory Affairs 

(OIRA) in the Office of Management and 

Budget (OMB). 

B. Review Under the Regulatory 

Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) requires preparation 

of an initial regulatory flexibility 

analysis for any rule that by law must 

be proposed for public comment, unless 

the agency certifies that the proposed 

rule, if promulgated, will not have a 

significant economic impact on a 

substantial number of small entities. As 

required by Executive Order 13272, 

‘‘Proper Consideration of Small Entities 

in Agency Rulemaking,’’ 67 FR 53461 

(August 16, 2002), DOE published 

procedures and policies on February 19, 

2003, to ensure that the potential 

impacts of its rules on small entities are 

properly considered during the 

rulemaking process. 68 FR 7990. DOE 

has made its procedures and policies 

available on the Office of the General 

Counsel’s Web site (http://

www.energy.gov/gc). 

DOE reviewed the amendments in the 

December 20, 2013 proposed rule under 

the provisions of the Regulatory 

Flexibility Act and the procedures and 

policies published on February 19, 

2003, and tentatively concluded that the 

proposed rule, if adopted, would not 

have a significant impact on small 

manufacturers under the provisions of 

the Regulatory Flexibility Act. These 

amendments add new statutory 

definitions for currently regulated 

products and have no impact on the 

applicable standards. These 

amendments also remove outdated 

regulatory requirements and do not 

otherwise change the regulatory 

framework for consumer products or 

commercial and industrial equipment 

that is currently in place. DOE received 

no comments objecting to this 

conclusion. For these reasons, DOE 

concludes and certifies that the rule 

would not have a significant economic 

impact on a substantial number of small 

entities and has not prepared a 

regulatory flexibility analysis. DOE has 

transmitted the certification and 

supporting statement of factual basis to 

the Chief Counsel for Advocacy of the 

SBA for review under 5 U.S.C. 605(b). 

C. Review Under the Paperwork 

Reduction Act of 1995 

Manufacturers of residential central 

air conditioners and heat pumps must 

certify to DOE that their products 

comply with any applicable energy 

conservation standards. In certifying 

compliance, manufacturers must test 

their products according to the DOE test 

procedures for residential central air 

conditioners and heat pumps, including 

any amendments to these procedures. 

DOE has established regulations for the 

certification and recordkeeping 

requirements for all covered consumer 

products and commercial equipment, 

including residential central air 

conditioners and heat pumps. (76 FR 

12422 (March 7, 2011)) The collectionof-information requirement for the 

certification and recordkeeping is 

subject to review and approval by OMB 

under the Paperwork Reduction Act 

(PRA). This requirement has been 

approved by OMB under OMB control 

number 1910–1400. Public reporting 

burden for the certification is estimated 

to average 20 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

Notwithstanding any other provision 

of the law, no person is required to 

respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection of information subject 

to the requirements of the PRA, unless 

that collection of information displays a 

currently valid OMB Control Number. 

D. Review Under the National 

Environmental Policy Act of 1969 

Pursuant to the National 

Environmental Policy Act of 1969, DOE 

has determined that this rule is covered 

under the Categorical Exclusion found 

in DOE’s National Environmental Policy 

Act regulations at paragraph A.6 of 

Appendix A to Subpart D, 10 CFR Part 

1021, which applies to rulemakings that 

are strictly procedural. Therefore, DOE 

does not need to prepare an 

Environmental Assessment or 

Environmental Impact Statement for 

this rule. 

E. Review Under Executive Order 13132 

Executive Order 13132, ‘‘Federalism,’’ 

imposes certain requirements on 

agencies formulating and implementing 

policies or regulations that preempt 

State law or that have Federalism 

implications. 64 FR 43255 (August 10, 

1999). The Executive Order requires 

agencies to examine the constitutional 

and statutory authority supporting any 

action that would limit the 

policymaking discretion of the States 

and to carefully assess the necessity for 

such actions. The Executive Order also 

requires agencies to have an accountable 

process to ensure meaningful and timely 

input by State and local officials in the 

development of regulatory policies that 

have Federalism implications. On 

March 14, 2000, DOE published a 

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Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 20093 

statement of policy describing the 

intergovernmental consultation process 

that it will follow in developing such 

regulations. 65 FR 13735. DOE 

examined this final rule and determined 

that it will not have a substantial direct 

effect on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. EPCA 

governs and prescribes Federal 

preemption of State regulations as to 

energy conservation for the products 

that are the subject of today’s final rule. 

States can petition DOE for exemption 

from such preemption to the extent, and 

based on criteria, set forth in EPCA. (42 

U.S.C. 6297) No further action is 

required by Executive Order 13132. 

F. Review Under Executive Order 12988 

Regarding the review of existing 

regulations and the promulgation of 

new regulations, section 3(a) of 

Executive Order 12988, ‘‘Civil Justice 

Reform,’’ 61 FR 4729 (Feb. 7, 1996), 

imposes on Federal agencies the general 

duty to adhere to the following 

requirements: (1) Eliminate drafting 

errors and ambiguity; (2) write 

regulations to minimize litigation; (3) 

provide a clear legal standard for 

affected conduct rather than a general 

standard; and (4) promote simplification 

and burden reduction. Section 3(b) of 

Executive Order 12988 specifically 

requires that Executive agencies make 

every reasonable effort to ensure that the 

regulation specifies the following: (1) 

The preemptive effect, if any; (2) any 

effect on existing Federal law or 

regulation; (3) a clear legal standard for 

affected conduct while promoting 

simplification and burden reduction; (4) 

the retroactive effect, if any; (5) 

definitions of key terms; and (6) other 

important issues affecting clarity and 

general draftsmanship under any 

guidelines issued by the Attorney 

General. Section 3(c) of Executive Order 

12988 requires Executive agencies to 

review regulations in light of applicable 

standards in sections 3(a) and 3(b) to 

determine whether they are met or 

whether it is unreasonable to meet one 

or more of them. DOE has completed the 

required review and determined that, to 

the extent permitted by law, this final 

rule meets the relevant standards of 

Executive Order 12988. 

G. Review Under the Unfunded 

Mandates Reform Act of 1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4; 2 U.S.C. 1501 et seq.) requires 

each Federal agency to assess the effects 

of Federal regulatory actions on State, 

local, and Tribal governments and the 

private sector. For a regulatory action 

resulting in a rule that may cause the 

expenditure by State, local, and Tribal 

governments, in the aggregate, or by the 

private sector of $100 million or more 

in any one year (adjusted annually for 

inflation), section 202 of UMRA requires 

a Federal agency to publish estimates of 

the resulting costs, benefits, and other 

effects on the national economy. (2 

U.S.C. 1532(a)–(b)) UMRA also requires 

a Federal agency to develop an effective 

process to permit timely input by 

elected officers of State, local, and 

Tribal governments on a proposed 

‘‘significant intergovernmental 

mandate,’’ and requires an agency plan 

for giving notice and opportunity for 

timely input to potentially-affected 

small governments before establishing 

any requirements that might 

significantly or uniquely affect such 

governments. On March 18, 1997, DOE 

published a statement of policy on its 

process for intergovernmental 

consultation under UMRA. 62 FR 

12820. (The policy is also available at 

www.energy.gov/gc). Today’s final rule 

contains neither an intergovernmental 

mandate nor a mandate that may result 

in an expenditure of $100 million or 

more in any year, so these requirements 

do not apply. 

H. Review Under the Treasury and 

General Government Appropriations 

Act, 1999 

Section 654 of the Treasury and 

General Government Appropriations 

Act, 1999 (Pub. L. 105–277) requires 

Federal agencies to issue a Family 

Policymaking Assessment for any rule 

that may affect family well-being. 

Today’s final rule would not have any 

impact on the autonomy or integrity of 

the family as an institution. 

Accordingly, DOE has concluded that it 

is not necessary to prepare a Family 

Policymaking Assessment. 

I. Review Under Executive Order 12630 

DOE has determined, under Executive 

Order 12630, ‘‘Governmental Actions 

and Interference with Constitutionally 

Protected Property Rights,’’ 53 FR 8859 

(March 18, 1988), that this regulation 

would not result in any takings that 

might require compensation under the 

Fifth Amendment to the U.S. 

Constitution. 

J. Review Under the Treasury and 

General Government Appropriations 

Act, 2001 

Section 515 of the Treasury and 

General Government Appropriations 

Act, 2001 (44 U.S.C. 3516 note) provides 

for agencies to review most 

disseminations of information to the 

public under guidelines established by 

each agency pursuant to general 

guidelines issued by OMB. OMB’s 

guidelines were published at 67 FR 

8452 (Feb. 22, 2002), and DOE’s 

guidelines were published at 67 FR 

62446 (Oct. 7, 2002). DOE has reviewed 

today’s final rule under OMB and DOE 

guidelines and has concluded that it is 

consistent with applicable policies in 

those guidelines. 

K. Review Under Executive Order 13211 

Executive Order 13211, ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use,’’ 66 FR 28355 (May 

22, 2001), requires Federal agencies to 

prepare and submit to OIRA a Statement 

of Energy Effects for any significant 

energy action. A ‘‘significant energy 

action’’ is defined as any action by an 

agency that promulgates or is expected 

to lead to promulgation of a final rule 

and that (1)(i) is a significant regulatory 

action under Executive Order 12866, or 

any successor order; and (ii) is likely to 

have a significant adverse effect on the 

supply, distribution, or use of energy; or 

(2) is designated by the Administrator of 

OIRA as a significant energy action. For 

any significant energy action, the agency 

must give a detailed statement of any 

adverse effects on energy supply, 

distribution, or use if the regulation is 

implemented, and of reasonable 

alternatives to the action and their 

expected benefits on energy supply, 

distribution, and use. Today’s regulatory 

action is not a significant regulatory 

action under Executive Order 12866. It 

has likewise not been designated as a 

significant energy action by the 

Administrator of OIRA. Moreover, it 

would not have a significant adverse 

effect on the supply, distribution, or use 

of energy. Therefore, it is not a 

significant energy action, and, 

accordingly, DOE has not prepared a 

Statement of Energy Effects. 

L. Review Under Section 32 of the 

Federal Energy Administration Act of 

1974 

Under section 301 of the DOE 

Organization Act (Pub. L. 95–91; 42 

U.S.C. 7101 et seq.), DOE must comply 

with section 32 of the Federal Energy 

Administration Act of 1974, as amended 

by the Federal Energy Administration 

Authorization Act of 1977 (FEAA). (15 

U.S.C. 788) Section 32 essentially 

provides in part that, where a rule 

authorizes or requires use of commercial 

standards, the rulemaking must inform 

the public of the use and background of 

such standards. In addition, section 

32(c) requires DOE to consult with the 

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20094 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations 

Attorney General and the Chairman of 

the Federal Trade Commission (FTC) 

concerning the impact of the 

commercial or industry standards on 

competition. 

The modifications to regulatory 

definitions addressed by this action do 

not incorporate testing methods 

contained in any new commercial 

standards not already referenced by the 

test procedures. 

IV. Approval of the Office of the 

Secretary 

The Secretary of Energy has approved 

publication of today’s final rule. 

List of Subjects in 10 CFR Part 430 

Administrative practice and 

procedure, Energy conservation, 

Household appliances. 

Issued in Washington, DC, on April 7, 

2014. 

David T. Danielson, 

Assistant Secretary, Energy Efficiency and 

Renewable Energy. 

For the reasons stated in the 

preamble, DOE amends part 430 of 

chapter II, subchapter D, of title 10, of 

the Code of Federal Regulations, as set 

forth below: 

PART 430—ENERGY CONSERVATION 

PROGRAM FOR CONSUMER 

PRODUCTS 

■ 1. The authority citation for part 430 

continues to read as follows: 

Authority: 42 U.S.C. 6291–6309; 28 U.S.C. 

2461 note. 

■ 2. Section 430.2 is amended by 

removing the definition of ‘‘through-thewall air conditioner and heat pump’’ 

and by adding, in alphabetical order, 

definitions for ‘‘through-the-wall central 

air conditioner’’ and ‘‘through-the-wall 

central air conditioning heat pump’’ to 

read as follows: 

§ 430.2 Definitions. 

* * * * * 

Through-the-wall central air 

conditioner means a central air 

conditioner that is designed to be 

installed totally or partially within a 

fixed-size opening in an exterior wall, 

and: 

(1) Is not weatherized; 

(2) Is clearly and permanently marked 

for installation only through an exterior 

wall; 

(3) Has a rated cooling capacity no 

greater than 30,000 Btu/hr; 

(4) Exchanges all of its outdoor air 

across a single surface of the equipment 

cabinet; and 

(5) Has a combined outdoor air 

exchange area of less than 800 square 

inches (split systems) or less than 1,210 

square inches (single packaged systems) 

as measured on the surface described in 

paragraph (4) of this definition. 

Through-the-wall central air 

conditioning heat pump means a heat 

pump that is designed to be installed 

totally or partially within a fixed-size 

opening in an exterior wall, and: 

(1) Is not weatherized; 

(2) Is clearly and permanently marked 

for installation only through an exterior 

wall; 

(3) Has a rated cooling capacity no 

greater than 30,000 Btu/hr; 

(4) Exchanges all of its outdoor air 

across a single surface of the equipment 

cabinet; and 

(5) Has a combined outdoor air 

exchange area of less than 800 square 

inches (split systems) or less than 1,210 

square inches (single packaged systems) 

as measured on the surface described in 

paragraph (4) of this definition. 

* * * * * 

■ 3. Section 430.32 is amended by: 

■ a. Revising the introductory text to 

paragraph (c); 

■ b. Removing paragraph (c)(1); 

■ c. Redesignating paragraphs (c)(2) 

through (c)(6) as (c)(1) through (c)(5) 

respectively; 

■ d. Removing footnote 1 to the table in 

newly redesignated paragraph (c)(1); 

■ e. Removing newly redesignated 

paragraphs (c)(1)(v)(A) and (v)(B); 

■ f. Further redesignating newly 

redesignated paragraph (c)(1)(vi) as 

paragraph (c)(1)(v); 

■ g. Further redesignating newly 

redesignated paragraphs (c)(1)(vii)(A) 

and (vii)(B) as paragraphs (c)(1)(vi)(A) 

and (vi)(B) respectively; 

■ h. Removing footnote 1 to the table in 

newly redesignated paragraph (c)(2); 

■ i. Amending newly redesignated 

paragraph (c)(3) by removing the 

reference to ‘‘(c)(3)’’ and adding in its 

place ‘‘(c)(2)’’; and 

■ j. Amending newly redesignated 

paragraph (c)(4), by removing the 

references to ‘‘(c)(3)’’ in both places and 

adding in their places, ‘‘(c)(2)’’. 

The revision reads as follows: 

§ 430.32 Energy and water conservation 

standards and their compliance dates. 

* * * * * 

(c) Central air conditioners and heat 

pumps. The energy conservation 

standards defined in terms of the 

heating seasonal performance factor are 

based on Region IV, the minimum 

standardized design heating 

requirement, and the sampling plan 

stated in § 429.16 of this chapter. 

* * * * * 

[FR Doc. 2014–08223 Filed 4–10–14; 8:45 am] 

BILLING CODE 6450–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2014–N–0355] 

Advisory Committee: Bone, 

Reproductive and Urologic Drugs 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

standing advisory committees’ 

regulations to change the name and 

function of the Advisory Committee for 

Reproductive Health Drugs. This action 

is being taken to reflect changes made 

to the charter for this advisory 

committee. 

DATES: This rule is effective April 11, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Hays, Committee Management 

Officer, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–8220. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing that the name of the 

Advisory Committee for Reproductive 

Health Drugs, which was established on 

March 23, 1978, has been changed. The 

Agency decided that the name ‘‘Bone, 

Reproductive and Urologic Drugs 

Advisory Committee’’ more accurately 

describes the subject areas for which the 

committee is responsible. The 

committee reviews and evaluates data 

on the safety and effectiveness of 

marketed and investigational human 

drug products for use in the practice of 

osteoporosis and metabolic bone 

disease, obstetrics, gynecology, urology 

and related specialties, and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

The Bone, Reproductive and Urologic 

Drugs Advisory Committee name was 

changed and its functions expanded in 

the charter renewal dated March 23, 

2014. In this final rule, FDA is revising 

21 CFR 14.100(c)(9) to reflect these 

changes. 

Publication of this final rule 

constitutes a final action on this change 

under the Administrative Procedure 

Act. Under 5 U.S.C. 553(b)(B) and (d) 

and 21 CFR 10.40(d) and (e), the Agency 

finds good cause to dispense with notice 

and public procedure and to proceed to 

an immediately effective regulation. 

Such notice and procedures are 

unnecessary and are not in the public 

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