65976 Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 

• Energy-related activities—Projects 

that promote traditional energy 

activities and practices that support 

conservation and help to mitigate the 

high costs of the purchase, 

transportation, and storage of fuel in 

Alaskan Villages, especially strategic 

energy plans that have been identified 

in tribally approved strategic energy 

plans. Examples include projects to 

implement renewable energy resources 

at the Village level such as bio-energy, 

geothermal, hydropower, solar, wind, or 

other methods appropriate to the 

geographical location. 

• Infrastructure—Developing Villagelevel infrastructure (transportation 

systems, communication, distribution 

networks, financial institutions, etc.) to 

support the Village workforce and to 

make sustainable business activity 

possible. 

• Subsistence—Enhancing 

subsistence and agricultural activities to 

retain or revitalize traditional food 

sources and practices at the Villagelevel. 

(c) Social Development: Projects that 

develop and implement culturally 

appropriate strategies to meet the social 

service needs of Alaska Natives. 

Examples of Alaska-Specific program 

areas of interest are: 

• Community living—Development 

and coordination of services to assist 

people with disabilities by helping them 

reach their maximum potential through 

increased independence, productivity, 

and integration within the Village 

community. 

• Early childhood education and 

development—Supporting stable and 

high-quality, culturally responsive early 

childhood programs, creating early 

childhood education and development 

jobs, and improving Village level 

planning and coordination of early 

childhood education and development 

programs. 

• Youth development—Improving the 

well-being of youth through life skills 

training at the Village level, workforce 

development, mentoring programs, 

substance abuse programs, and 

preventing suicides and juvenile crime. 

• Community Health—Promoting 

improved access to health care and 

quality of care through coordinated 

Village and regional approaches, 

expanding access to healthy foods 

available in Native Villages, and 

supporting environmental health. 

• Arts and culture—Developing or 

enhancing activities, at the Village level 

that promote, preserve, or restore Native 

Village culture and arts. 

• Rescue archaeology—Recovery of 

cultural material due to climate change 

such as exposure of cultural artifacts 

due to permafrost melting. 

• Organizational Development— 

Increasing organizational capacity at the 

Village level to successfully implement 

mission and goals. 

• Nutrition and Fitness—Promoting 

increased knowledge and participation 

in activities that promote healthy foods, 

active lifestyles, the reduction of 

obesity, and other healthy-living habits 

• Strengthening Families— 

Incorporating culturally relevant 

strategies to strengthen families and 

promote family preservation, 

responsible parenting, and healthy 

relationship skills; and to foster the 

well-being of children residing in 

Villages 

• Responsible Fatherhood— 

Supporting responsible fatherhood 

through activities such as counseling, 

mentoring, marriage education, 

enhancing relationship skills, parenting, 

and activities to foster economic 

stability 

• Suicide Prevention—Promoting 

safety, resilience, and protective factors 

necessary to foster mental health and 

reduce incidences of suicide and 

suicidal ideation 

• Human Trafficking—Development 

of Village-level assessments and 

strategies to address human trafficking, 

including efforts to bring awareness of 

human trafficking to the public, 

development of prevention strategies to 

address the needs of victims, and 

establishment of collaborative 

partnerships including those that train 

public safety officials to recognize 

traffickers and their victims. 

C. Eligible Applicants 

Applicants eligible under the AlaskaSpecific SEDS FOA are those listed in 

45 CFR 1336.33(a)(2): that is, ‘‘(i) 

Federally recognized Indian tribes in 

Alaska; (ii) Alaska Native villages as 

defined in the Alaska Native Claims 

Settlement Act (ANSCA) and/or nonprofit village consortia; (iii) 

Incorporated nonprofit Alaska Native 

multi-purpose community-based 

organizations; (iv) Nonprofit Alaska 

Native Regional Corporations/ 

Associations in Alaska with village 

specific projects; and (v) Nonprofit 

Native organizations in Alaska with 

village specific projects.’’ As this listing 

already appears in our regulations we 

are not seeking comment on this aspect 

of the Alaska-Specific SEDS Projects. 

Statutory Authority: This notice for public 

comment is required by Section 814 of the 

Native American Programs Act of 1974 

(NAPA), as amended. 

Kimberly Romine, 

Deputy Commissioner, Administration for 

Native American. 

[FR Doc. 2014–26426 Filed 11–5–14; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0509] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Appeals of 

Science-Based Decisions Above the 

Division Level at the Center for 

Veterinary Medicine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

for appeals of science-based decisions 

above the division level at the Center for 

Veterinary Medicine (CVM). 

DATES: Submit electronic or written 

comments on the collection of 

information by January 5, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 65977 

1There are no capital costs or operating and 

maintenance costs associated with this collection of 

information. 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Appeals of Science-Based Decisions 

Above the Division Level at CVM—21 

CFR Part 10.75 (OMB Control Number 

0910–0566)—Revision 

Respondents: Respondents to this 

collection of information are applicants 

that wish to submit a request for review 

of a scientific dispute. 

CVM’s Guidance for Industry #79— 

‘‘Dispute Resolution Procedures for 

Science-based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine,’’ describes the process by 

which CVM formally resolves disputes 

relating to scientific controversies. A 

scientific controversy involves issues 

concerning a specific product regulated 

by CVM related to matters of technical 

expertise and requires specialized 

education, training, or experience to be 

understood and resolved. Further, the 

guidance details information on how the 

Agency intends to interpret and apply 

provisions of the existing regulations 

regarding internal Agency review of 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants or 

manufacturers, for animal drugs or other 

products regulated by CVM, that wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established Agency 

channels of supervision for review. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.75 .................................................................................... 2 4 8 10 80 

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method, then 

CVM recommends that the applicant 

follow the procedure in Guidance for 

Industry #79. Of the two respondents 

who were advised on the procedure 

during the past 3 years, one has not 

followed up to initiate it and the other 

is working with the review team/group 

to resolve the issue(s). Therefore, this 

estimated annual reporting burden is 

based on CVM’s previous experience in 

handling formal appeals for scientific 

disputes. 

Dated: October 31, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26307 Filed 11–5–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0984] 

Specification of the Unique Facility 

Identifier System for Drug 

Establishment Registration; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Specification of the Unique 

Facility Identifier (UFI) System for Drug 

Establishment Registration.’’ This 

guidance specifies the UFI system for 

registration of domestic and foreign 

drug establishments. The guidance 

addresses provisions set forth in the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), as amended by the Food 

and Drug Administration Safety and 

Innovation Act (FDASIA). This 

guidance finalizes the draft guidance 

issued on September 6, 2013. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993; or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

mstockstill on DSK4VPTVN1PROD with NOTICES