78794 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

related issue. The review is conducted 

at the discretion of OASCR or if there 

has been a formal finding of noncompliance. 

(g) Conducted programs and activities 

means the program services, benefits, or 

resources delivered directly to the 

public by USDA. 

(h) Days mean calendar days, not 

business days. 

(i) Department (used interchangeably 

with USDA) means the Department of 

Agriculture and includes each of its 

operating agencies and other 

organizational units. 

(j) Discrimination means unlawful 

treatment or denial of benefits, services, 

rights, or privileges to a person or 

persons based on race, color, national 

origin, religion, sex (including gender 

identity), sexual orientation, disability, 

age, marital status, sexual orientation, 

familial status, parental status, income 

derived from a public assistance 

program, political beliefs, or gender 

identity. 

(k) Secretary means the Secretary of 

Agriculture or any officer or employee 

of the Department whom the Secretary 

has heretofore delegated, or whom the 

Secretary may hereafter delegate, the 

authority to act in his or her stead under 

the regulations in this part. 

§ 15d.3 Discrimination prohibited. 

(a) No agency, officer, or employee of 

USDA shall, on the grounds of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, 

disability, age, marital status, family/

parental status, income derived from a 

public assistance program, or political 

beliefs, exclude from participation in, 

deny the benefits of, or subject to 

discrimination any person in the United 

States under any program or activity 

conducted by USDA. 

(b) No person shall be subjected to 

reprisal for opposing any practice(s) 

prohibited by this part, for filing a 

complaint, or for participating in any 

other manner in a proceeding under this 

part. 

§ 15d.4 Compliance. 

(a) Compliance program. OASCR shall 

evaluate each agency’s efforts to comply 

with this part and shall make 

recommendations for improving such 

efforts. 

(1) OASCR shall oversee the 

compliance reviews and evaluations, 

and issue compliance reports that 

monitor compliance efforts to ensure 

that there is equitable and fair treatment 

in conducted programs. 

(2) OASCR shall monitor all 

settlement agreements pertaining to 

program complaints for compliance to 

ensure full implementation and 

enforcement. 

(3) OASCR shall oversee Agency Head 

Assessments to ensure that Agency 

Heads are in compliance with civil 

rights laws and regulations. 

(4) OASCR shall monitor all findings 

of non-compliance to ensure that 

compliance is achieved. 

(5) OASCR shall require agencies to 

collect the race, ethnicity, and gender of 

applicants and program participants, 

who choose to provide such information 

on a voluntary basis, in USDAconducted programs, for purposes of 

civil rights compliance, oversight, and 

evaluation. 

(b) Agency data collection and 

compliance reports. (1) Each Agency 

shall, for civil rights compliance, 

collect, maintain, and annually compile 

data on all program applicants and 

participants in conducted programs by 

county and State, including but not 

limited to, application and participation 

rate data regarding socially 

disadvantaged and limited resources 

applicants and participants. At a 

minimum, the data should include: 

(i) Numbers of applicants and 

participants by race, ethnicity, and 

gender, subject to appropriate privacy 

protections, as determined by the 

Secretary and in accordance with law; 

and 

(ii) The application and participation 

rate, by race, ethnicity, and gender, as 

a percentage of the total participation 

rate. 

(2) Each Agency shall submit to 

OASCR timely, complete, and accurate 

program application and participation 

reports containing the information 

described in paragraph (b)(1) of this 

section, on an annual basis, and upon 

the request of OASCR independently of 

the annual requirement. 

(c) Complaint reporting compliance. 

OASCR shall ensure compliance with 

mandated complaint reporting 

requirements, such as those required by 

section 14006 of the Food, 

Conservation, and Energy Act of 2008 

(PL 110–246). 

§ 15d.5 Complaints. 

(a) Any person who believes that he 

or she (or any specific class of 

individuals) has been, or is being, 

subjected to practices prohibited by this 

part may file (or file through an 

authorized representative) a written 

complaint alleging such discrimination. 

The written complaint must be filed 

within 180 calendar days from the date 

the person knew or reasonably should 

have known of the alleged 

discrimination, unless the time is 

extended for good cause by ASCR or the 

designee. Any person who complains of 

discrimination under this part in any 

fashion shall be advised of the right to 

file a complaint as herein provided. 

(b) All complaints under this part 

should be filed with the Office of the 

Assistant Secretary for Civil Rights 

(ASCR), 1400 Independence Ave SW., 

U.S. Department of Agriculture, 

Washington, DC 20250, who will 

investigate the complaints. The ASCR 

will make final determinations as to the 

merits of complaints under this part and 

as to the corrective actions required to 

resolve program complaints. The 

complainant will be notified of the final 

determination on the complaint. 

(c) Any complaint filed under this 

part alleging discrimination on the basis 

of disability will be processed under 7 

CFR part 15e. 

(d) For complaints OASCR deems 

appropriate for ADR, OASCR shall offer 

ADR services to complainants. 

Dated: December 19, 2013. 

Krysta Harden, 

Deputy Secretary. 

[FR Doc. 2013–30812 Filed 12–26–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2013–0957; Airspace 

Docket No. 13–AWP–18] 

Proposed Establishment of Class E 

Airspace; Flagstaff, AZ 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

establish Class E airspace at the Flagstaff 

VHF Omni-Directional Radio Range/

Distance Measuring Equipment (VOR/

DME) navigation aid, Flagstaff, AZ, to 

facilitate vectoring of Instrument Flight 

Rules (IFR) aircraft under control of 

Albuquerque Air Route Traffic Control 

Center (ARTCC). The FAA is proposing 

this action to enhance the safety and 

management of aircraft operations 

within the National Airspace System. 

DATES: Comments must be received on 

or before February 10, 2014. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590; telephone (202) 

366–9826. You must identify FAA 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 78795 

Docket No. FAA–2013–0957; Airspace 

Docket No. 13–AWP–18, at the 

beginning of your comments. You may 

also submit comments through the 

Internet at http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Eldon Taylor, Federal Aviation 

Administration, Operations Support 

Group, Western Service Center, 1601 

Lind Avenue SW., Renton, WA 98057; 

telephone (425) 203–4537. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers (FAA Docket No. FAA 

2013–0957 and Airspace Docket No. 13– 

AWP–18) and be submitted in triplicate 

to the Docket Management System (see 

ADDRESSES section for address and 

phone number). You may also submit 

comments through the Internet at 

http://www.regulations.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2013–0957 and 

Airspace Docket No. 13–AWP–18’’. The 

postcard will be date/time stamped and 

returned to the commenter. 

All communications received on or 

before the specified closing date for 

comments will be considered before 

taking action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s Web page at http://

www.faa.gov/airports_airtraffic/air_

traffic/publications/

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see the 

ADDRESSES section for the address and 

phone number) between 9:00 a.m. and 

5:00 p.m., Monday through Friday, 

except federal holidays. An informal 

docket may also be examined during 

normal business hours at the Northwest 

Mountain Regional Office of the Federal 

Aviation Administration, Air Traffic 

Organization, Western Service Center, 

Operations Support Group, 1601 Lind 

Avenue SW., Renton, WA 98057. 

Persons interested in being placed on 

a mailing list for future NPRMs should 

contact the FAA’s Office of Rulemaking, 

(202) 267–9677, for a copy of Advisory 

Circular No. 11–2A, Notice of Proposed 

Rulemaking Distribution System, which 

describes the application procedure. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) Part 71 by establishing Class E 

en route domestic airspace extending 

upward from 1,200 feet above the 

surface at the Flagstaff VOR/DME 

navigation aid, Flagstaff, AZ. This 

action would contain aircraft while in 

IFR conditions under control of 

Albuquerque ARTCC by vectoring 

aircraft from en route airspace to 

terminal areas. 

Class E airspace designations are 

published in paragraph 6006, of FAA 

Order 7400.9X, dated August 7, 2013, 

and effective September 15, 2013, which 

is incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document will be 

published subsequently in this Order. 

The FAA has determined this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 

Therefore, this proposed regulation; (1) 

is not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified this proposed rule, when 

promulgated, would not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

Section 106, describes the authority for 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of the airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it would 

establish controlled airspace at the 

Flagstaff VOR/DME navigation aid, 

Flagstaff, AZ. 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1E, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me, the Federal 

Aviation Administration proposes to 

amend 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of the Federal Aviation 

Administration Order 7400.9X, Airspace 

Designations and Reporting Points, 

dated August 7, 2013, and effective 

September 15, 2013 is amended as 

follows: 

Paragraph 6006 En route domestic airspace 

areas 

* * * * * 

AWP AZ E6 Flagstaff, AZ [New] 

Flagstaff VOR/DME, AZ 

(Lat. 35°08′50′′ N., long. 111°40′27′′ W.) 

That airspace extending upward from 

1,200 feet above the surface within an area 

bounded by lat. 35°51′00′′ N., long. 

109°19′00′′ W.; to lat. 35°41′00′′ N., long. 

109°38′30′′ W.; to lat. 34°47′52′′ N., long. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
78796 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 

110°18′52′′ W.; to lat. 34°30′00′′ N., long. 

109°35′00′′ W.; to lat. 34°00′00′′ N., long. 

108°53′00′′ W.; to lat. 33°52′30′′ N., long. 

108°45′00′′ W.; to lat. 32°29′30′′ N., long. 

110°45′45′′ W.; to lat. 33°33′12′′ N., long. 

111°51′21′′ W.; to lat. 34°01′00′′ N., long. 

114°00′00′′ W.; to lat. 34°40′00′′ N., long. 

114°00′00′′ W.; to lat. 34°52′00′′ N., long. 

113°42′00′′ W.; to lat. 34°55′00′′ N., long. 

113°37′00′′ W.; to lat. 35°15′20′′ N., long. 

112°55′40′′ W.; to lat. 35°23′00′′ N., long. 

112°40′00′′ W.; to lat. 35°23′48′′ N., long. 

112°09′11′′ W.; to lat. 35°24′00′′ N., long. 

112°00′00′′ W.; to lat. 35°46′00′′ N., long. 

111°50′30′′ W.; to lat. 35°42′00′′ N., long. 

110°14′00′′ W., thence to the point of 

beginning. 

Issued in Seattle, Washington, on 

December 11, 2013. 

Christopher Ramirez, 

Acting Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. 2013–31093 Filed 12–26–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

RIN 0910–AG94 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products; Correction 

and Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; correction and 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting, and 

extending the comment period for, the 

proposed rule that appeared in the 

Federal Register of November 13, 2013. 

In the proposed rule, FDA requested 

comments on the proposal to revise and 

clarify procedures for application 

holders of an approved drug or 

biological product to change the product 

labeling to reflect certain types of newly 

acquired information in advance of 

FDA’s review of the change. The 

proposed rule published without a 

reference or a link to the accompanying 

Regulatory Impact Analysis. The 

Agency is taking this action to correct 

this omission and to extend the 

comment period in response to requests 

for an extension to allow interested 

persons additional time to submit 

comments on the proposed rule. 

DATES: FDA is extending the comment 

period on the proposed rule published 

November 13, 2013, at 78 FR 67985, and 

on information collection issues under 

the Paperwork Reduction Act of 1995. 

Submit either electronic or written 

comments on the proposed rule by 

March 13, 2014. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

February 11, 2014 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of the 

proposed rule). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2013–N– 

0500 and/or Regulatory Information 

Number (RIN) 0910–AG94, by any of the 

following methods, except that 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 must be submitted to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of the 

proposed rule. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2013–N–0500 and RIN 

0910–AG94 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Janice L. Weiner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6304, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

13, 2013 (78 FR 67985), FDA published 

a proposed rule with a 60-day comment 

period to request comments on the 

proposal to revise and clarify 

procedures for application holders of an 

approved drug or biological product to 

change the product labeling to reflect 

certain types of newly acquired 

information in advance of FDA’s review 

of the change. Comments on the 

proposal to permit holders of 

abbreviated new drug applications to 

distribute revised product labeling that 

differs in certain respects, on a 

temporary basis, from the labeling of its 

reference listed drug upon submission 

of a ‘‘changes being effected’’ 

supplement will inform FDA’s 

rulemaking. 

The proposed rule published without 

reference or a link to the accompanying 

Regulatory Impact Analysis. 

Accordingly, the following corrections 

are made to FR Doc. 2013–26799, 

appearing on page 67985, in the Federal 

Register of November 13, 2013: 

1. On page 67996, in the first column, 

at the end of section IV. Analysis of 

Impacts, the following is added as a 

third full paragraph: ‘‘The full 

discussion of economic impacts is 

available in docket FDA–2013–N–0500 

and at http://www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/

EconomicAnalyses/default.htm (Ref. 

3).’’ 

2. On page 67997, in the third 

column, the following is added as a 

third reference: ‘‘3. Preliminary 

Regulatory Impact Analysis, Initial 

Regulatory Flexibility Analysis, and 

Unfunded Mandates Reform Act 

Analysis for Supplemental Applications 

Proposing Labeling Changes for 

Approved Drugs and Biological 

Products, available at http://

www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/

EconomicAnalyses/default.htm.’’ 

The Agency has received requests for 

a 60-day extension of the comment 

period for the proposed rule. These 

requests conveyed concern that the 

current 60-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the proposed rule. 

FDA has considered the requests and 

is extending the comment period for the 

proposed rule for 60 days, until March 

13, 2014. FDA also is extending the 

comment period for information 

collection issues under the Paperwork 


tkelley on DSK3SPTVN1PROD with PROPOSALS