17446 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 

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. 

Animal Food Labeling; Declaration of 

Certifiable Color Additives—21 CFR 

501.22(k) (OMB Control Number 0910– 

0721—Extension) 

This information collection is 

associated with requirements under 

§ 501.22(k) (21 CFR 501.22(k)) in which 

animal food manufacturers must declare 

the presence of certified and 

noncertified color additives in their 

animal food products on the product 

label. The Agency issued this regulation 

in response to the Nutrition Labeling 

and Education Act of 1990 to make 

animal food regulations consistent with 

the regulations regarding the declaration 

of color additives on human food labels 

and to provide animal owners with 

information on the colors used in 

animal food. 

Respondents to this collection are 

manufacturers of pet food that contain 

color additives. Manufacturers of certain 

food or food ingredients do not have 

products that contain color additives 

requiring certification (e.g., food for 

chickens, fish, and some other species, 

including some pet foods) and would 

thus be minimally affected by 

§ 501.22(k)(1). However, since we 

cannot rule out the possibility that they 

may at some point use a color additive 

requiring certification, we have 

consolidated the burden estimates for 

§ 501.22(k)(1) and (k)(2). Additionally, 

we believe that this burden is more 

accurately characterized as a third-party 

disclosure burden because FDA does 

not require routine submission of pet 

food labeling to the Agency. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification 3,120 0.83 2,587 0.25 647 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Because § 501.22(k) became effective 

November 18, 2013, the Agency 

estimates that the burden associated 

with the labeling requirements under 

§ 501.22(k) applies only to new product 

labels. Because the vast majority of 

animal food products that contain 

certified color additives are pet foods, 

we limit our burden estimate to 

reviewing labels for the use of certified 

color additives to pet food 

manufacturers subject to this regulation. 

Based on A.C. Nielsen Data, FDA 

estimates that the number of animal 

food product units subject to § 501.22(k) 

for which sales of the products are 

greater than zero is 25,874. Assuming 

that the flow of new products is 10 

percent per year, then 2,587 new animal 

food products subject to § 501.22(k) will 

come on the market each year. FDA also 

estimates that there are about 3,120 

manufacturers of pet food subject to 

either § 501.22(k)(1) or (k)(2). Assuming 

the approximately 2,587 new products 

are split equally among the firms, then 

each firm would prepare labels for 

approximately 0.83 new products per 

year (2,587 new products/3,120 firms is 

approximately 0.83 labels per firm). 

The Agency expects that firms 

prepare the required labeling for their 

products in a manner that takes into 

account at one time all information 

required to be disclosed on their 

product labels. Based on our experience 

with reviewing pet food labeling, FDA 

estimates that firms would require less 

than 0.25 hour (15 minutes) per product 

to comply with the requirement to 

include the color additive information 

under § 501.22(k). The total burden of 

this activity is 647 hours (2,587 labels 

x 0.25 hour/label is approximately 647 

hours). 

Dated: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07420 Filed 3–31–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; Review of Alcohol Health 

Disparity Research Centers. 

Date: April 28, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIAAA, NIH, 5635 Fishers Lane, 

Rockville, MD 20852, (Telephone Conference 

Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch, 

National Institute on Alcohol Abuse and 

Alcoholism, NIH, 5635 Fishers Lane, Room 

2085, Rockville, MD 20852, (301) 443–2067, 

srinivar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 92.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17447 

93.701, ARRA Related Biomedical Research 

and Research Supports Awards, National 

Institutes of Health, HHS) 

Dated: March 26, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07343 Filed 3–31–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Immune 

System and Aging. 

Date: April 15, 2015. 

Time: 9:45 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2C212, 7201 

Wisconsin Avenue, Bethesda, MD 20892. 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC., Scientific Review Branch, 

National Institute on Aging, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 20892, 

301–496–9666, markowsa@nia.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; 

Neuromuscular Interactions. 

Date: April 22, 2015. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2C212, 7201 

Wisconsin Avenue, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC., Scientific Review Branch, 

National Institute on Aging, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 20892, 

301–496–9666, markowsa@nia.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: March 26, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07339 Filed 3–31–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Privacy Act of 1974; System of 

Records Notice 

AGENCY: Office of the Secretary (OS), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice to establish a new system 

of records and delete an existing system 

of records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended (5 U.S.C. 552a), HHS is 

establishing a new department-wide 

system of records, ‘‘Records about 

Restricted Dataset Requesters,’’ System 

Number 09–90–1401, to cover records 

about individuals within and outside 

HHS who request restricted datasets and 

software products from HHS (e.g., for 

health-related scientific research and 

study purposes), when HHS maintains 

the requester records in a system from 

which they are retrieved directly by an 

individual requester’s name or other 

personal identifier. The System of 

Records Notice (SORN) previously 

published at 78 FR 32654 for ‘‘Online 

Application Ordering for Products from 

the Healthcare Cost and Utilization 

Project (HCUP),’’ System Number 09– 

35–0003, is being deleted and replaced 

by this new department-wide SORN. 

DATES: Effective Dates: The departmentwide SORN proposed in this Notice is 

effective upon publication, with the 

exception of the routine uses. The 

routine uses will be effective 30 days 

after publication of this Notice, unless 

comments are received that warrant 

revisions to this Notice. Written 

comments on the routine uses should be 

submitted within 30 days. The deletion 

of System Number 09–35–0003 will be 

effective 30 days after publication of 

this Notice. 

ADDRESSES: The public should address 

written comments to: Beth Kramer, HHS 

Privacy Act Officer, Mary E. Switzer 

Building—Room 2210, 330 C Street 

SW., Washington, DC 20201, 

beth.kramer@hhs.gov. Comments will 

be available for public viewing at the 

same location. To review comments in 

person, please contact Beth Kramer at 

beth.kramer@hhs.gov or (202) 690–6941. 

FOR FURTHER INFORMATION CONTACT: Beth 

Kramer, HHS Privacy Act Officer, Mary 

E. Switzer Building—Room 2210, 330 C 

Street SW., Washington, DC 20201, 

beth.kramer@hhs.gov. 

SUPPLEMENTARY INFORMATION: The new 

system of records will cover records 

about individuals within and outside 

HHS who request restricted datasets and 

software products from HHS, when HHS 

maintains the requester records in a 

system from which they are retrieved 

directly by an individual requester’s 

name or other personal identifier. 

‘‘Restricted’’ datasets and software 

products are those that HHS makes 

affirmatively available to qualified 

members of the public but provides 

subject to restrictions, because they 

contain identifiable data and/or 

anonymized data that has the potential, 

when combined with other data, to 

identify the particular individuals, such 

as patients or providers, whose 

information is represented in the data. 

The datasets and products are made 

available through an on-line or paperbased ordering and delivery system that 

provides them to qualified requesters 

electronically or by mail. 

The restrictions are necessary to 

protect the privacy of individuals whose 

information is represented in the 

datasets or software products. The 

restrictions typically limit the data 

requester to using the data for research, 

analysis, study, and aggregate statistical 

reporting; prohibit any attempt to 

identify any individual or establishment 

represented in the data; and require 

specific security measures to safeguard 

the data from unauthorized access. HHS 

is required by law to impose, monitor, 

and enforce the restrictions (see, for 

example, provisions in the Confidential 

Information Protection and Statistical 

Efficiency Act of 2002 (CIPSEA), 44 

U.S.C. 3501 at note). To impose and 

enforce the restrictions, it is necessary 

to collect information about the data 

requesters. 

Currently, this system of records 

covers data requester records in 

ordering and delivery systems 

administered by three HHS Operating 

Divisions, but only to the extent that the 

records pertain to requesters seeking 

restricted datasets. These ordering and 

delivery systems retrieve requester 

records directly by personal identifier: 

mstockstill on DSK4VPTVN1PROD with NOTICES