80 FR 17446 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 62 (April 1, 2015)

Page Range		17446-17447
FR Document		2015-07343

Federal Register, Volume 80 Issue 62 (Wednesday, April 1, 2015)

[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17446-17447]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07343]


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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, [email protected].

(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;

[[Page 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

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

before submitting the collection to OMB when appropriate, and other forms of Respondents to this collection are
for approval. To comply with this information technology. manufacturers of pet food that contain
requirement, FDA is publishing notice color additives. Manufacturers of certain
Animal Food Labeling; Declaration of
of the proposed collection of food or food ingredients do not have
Certifiable Color Additives—21 CFR
information set forth in this document. products that contain color additives
With respect to the following 501.22(k) (OMB Control Number 0910–
0721—Extension) requiring certification (e.g., food for
collection of information, FDA invites chickens, fish, and some other species,
comments on these topics: (1) Whether This information collection is including some pet foods) and would
the proposed collection of information associated with requirements under thus be minimally affected by
is necessary for the proper performance § 501.22(k) (21 CFR 501.22(k)) in which
§ 501.22(k)(1). However, since we
of FDA’s functions, including whether animal food manufacturers must declare
cannot rule out the possibility that they
the information will have practical the presence of certified and
may at some point use a color additive
utility; (2) the accuracy of FDA’s noncertified color additives in their
requiring certification, we have
estimate of the burden of the proposed animal food products on the product
consolidated the burden estimates for
collection of information, including the label. The Agency issued this regulation
validity of the methodology and in response to the Nutrition Labeling § 501.22(k)(1) and (k)(2). Additionally,
assumptions used; (3) ways to enhance and Education Act of 1990 to make we believe that this burden is more
the quality, utility, and clarity of the animal food regulations consistent with accurately characterized as a third-party
information to be collected; and (4) the regulations regarding the declaration disclosure burden because FDA does
ways to minimize the burden of the of color additives on human food labels not require routine submission of pet
collection of information on and to provide animal owners with food labeling to the Agency.
respondents, including through the use information on the colors used in FDA estimates the burden for this
of automated collection techniques, animal food. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Section; activity burden per Total hours
respondents per respond- disclosures disclosure
ent

501.22(k); labeling of color additive or lake of color addi-
tive; labeling of color additives not subject to certification 3,120 0.83 2,587 0.25 647
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Because § 501.22(k) became effective account at one time all information provisions set forth in sections
November 18, 2013, the Agency required to be disclosed on their 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
estimates that the burden associated product labels. Based on our experience as amended. The grant applications and
with the labeling requirements under with reviewing pet food labeling, FDA the discussions could disclose
§ 501.22(k) applies only to new product estimates that firms would require less confidential trade secrets or commercial
labels. Because the vast majority of than 0.25 hour (15 minutes) per product property such as patentable material,
animal food products that contain to comply with the requirement to and personal information concerning
certified color additives are pet foods, include the color additive information individuals associated with the grant
we limit our burden estimate to under § 501.22(k). The total burden of applications, the disclosure of which
reviewing labels for the use of certified this activity is 647 hours (2,587 labels would constitute a clearly unwarranted
color additives to pet food x 0.25 hour/label is approximately 647 invasion of personal privacy.
manufacturers subject to this regulation. hours). Name of Committee: National Institute on
Based on A.C. Nielsen Data, FDA Dated: March 25, 2015. Alcohol Abuse and Alcoholism Special
estimates that the number of animal Leslie Kux, Emphasis Panel; Review of Alcohol Health
food product units subject to § 501.22(k) Disparity Research Centers.
Associate Commissioner for Policy.
for which sales of the products are Date: April 28, 2015.
[FR Doc. 2015–07420 Filed 3–31–15; 8:45 am] Time: 1:00 p.m. to 5:00 p.m.
greater than zero is 25,874. Assuming BILLING CODE 4164–01–P Agenda: To review and evaluate grant
that the flow of new products is 10 applications.
percent per year, then 2,587 new animal Place: NIAAA, NIH, 5635 Fishers Lane,
food products subject to § 501.22(k) will DEPARTMENT OF HEALTH AND Rockville, MD 20852, (Telephone Conference
come on the market each year. FDA also HUMAN SERVICES Call).
estimates that there are about 3,120 Contact Person: Ranga Srinivas, Ph.D.,
manufacturers of pet food subject to National Institutes of Health Chief, Extramural Project Review Branch,
either § 501.22(k)(1) or (k)(2). Assuming National Institute on Alcohol Abuse and
the approximately 2,587 new products National Institute on Alcohol Abuse Alcoholism, NIH, 5635 Fishers Lane, Room
are split equally among the firms, then and Alcoholism; Notice of Closed 2085, Rockville, MD 20852, (301) 443–2067,
mstockstill on DSK4VPTVN1PROD with NOTICES

Meeting srinivar@mail.nih.gov.
each firm would prepare labels for
approximately 0.83 new products per (Catalogue of Federal Domestic Assistance
Pursuant to section 10(d) of the Program Nos. 93.271, Alcohol Research
year (2,587 new products/3,120 firms is Federal Advisory Committee Act, as
approximately 0.83 labels per firm). Career Development Awards for Scientists
amended (5 U.S.C. App.), notice is and Clinicians; 93.272, Alcohol National
The Agency expects that firms hereby given of the following meeting. Research Service Awards for Research
prepare the required labeling for their The meeting will be closed to the Training; 92.273, Alcohol Research Programs;
products in a manner that takes into public in accordance with the 93.891, Alcohol Research Center Grants;

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

93.701, ARRA Related Biomedical Research This notice is being published less than 15 Building—Room 2210, 330 C Street
and Research Supports Awards, National days prior to the meeting due to the timing SW., Washington, DC 20201,
Institutes of Health, HHS) limitations imposed by the review and beth.kramer@hhs.gov. Comments will
funding cycle.
Dated: March 26, 2015. be available for public viewing at the
Melanie J. Gray, (Catalogue of Federal Domestic Assistance same location. To review comments in
Program Nos. 93.866, Aging Research, person, please contact Beth Kramer at
Program Analyst, Office of Federal Advisory
National Institutes of Health, HHS) beth.kramer@hhs.gov or (202) 690–6941.
Committee Policy.
[FR Doc. 2015–07343 Filed 3–31–15; 8:45 am] Dated: March 26, 2015.
FOR FURTHER INFORMATION CONTACT: Beth
BILLING CODE 4140–01–P Melanie J. Gray, Kramer, HHS Privacy Act Officer, Mary
Program Analyst, Office of Federal Advisory E. Switzer Building—Room 2210, 330 C
Committee Policy. Street SW., Washington, DC 20201,
DEPARTMENT OF HEALTH AND [FR Doc. 2015–07339 Filed 3–31–15; 8:45 am] beth.kramer@hhs.gov.
HUMAN SERVICES BILLING CODE 4140–01–P
SUPPLEMENTARY INFORMATION: The new
National Institutes of Health system of records will cover records
DEPARTMENT OF HEALTH AND about individuals within and outside
National Institute on Aging; Notice of HUMAN SERVICES HHS who request restricted datasets and
Closed Meetings software products from HHS, when HHS
Office of the Secretary maintains the requester records in a
Pursuant to section 10(d) of the system from which they are retrieved
Federal Advisory Committee Act, as Privacy Act of 1974; System of directly by an individual requester’s
amended (5 U.S.C. App.), notice is Records Notice name or other personal identifier.
hereby given of the following meetings. ‘‘Restricted’’ datasets and software
AGENCY: Office of the Secretary (OS),
The meetings will be closed to the Department of Health and Human products are those that HHS makes
public in accordance with the Services (HHS). affirmatively available to qualified
provisions set forth in sections members of the public but provides
ACTION: Notice to establish a new system
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., subject to restrictions, because they
of records and delete an existing system
as amended. The grant applications and contain identifiable data and/or
of records.
the discussions could disclose anonymized data that has the potential,
confidential trade secrets or commercial SUMMARY: In accordance with the when combined with other data, to
property such as patentable material, requirements of the Privacy Act of 1974, identify the particular individuals, such
and personal information concerning as amended (5 U.S.C. 552a), HHS is as patients or providers, whose
individuals associated with the grant establishing a new department-wide information is represented in the data.
applications, the disclosure of which system of records, ‘‘Records about The datasets and products are made
would constitute a clearly unwarranted Restricted Dataset Requesters,’’ System available through an on-line or paper-
invasion of personal privacy. Number 09–90–1401, to cover records based ordering and delivery system that
Name of Committee: National Institute on about individuals within and outside provides them to qualified requesters
Aging Special Emphasis Panel; Immune HHS who request restricted datasets and electronically or by mail.
System and Aging. software products from HHS (e.g., for The restrictions are necessary to
Date: April 15, 2015. health-related scientific research and protect the privacy of individuals whose
Time: 9:45 a.m. to 1:00 p.m. study purposes), when HHS maintains information is represented in the
Agenda: To review and evaluate grant the requester records in a system from datasets or software products. The
applications. which they are retrieved directly by an restrictions typically limit the data
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
individual requester’s name or other requester to using the data for research,
Wisconsin Avenue, Bethesda, MD 20892. personal identifier. The System of analysis, study, and aggregate statistical
Contact Person: Alicja L. Markowska, Records Notice (SORN) previously reporting; prohibit any attempt to
Ph.D., DSC., Scientific Review Branch, published at 78 FR 32654 for ‘‘Online identify any individual or establishment
National Institute on Aging, 7201 Wisconsin Application Ordering for Products from represented in the data; and require
Avenue, Suite 2C212, Bethesda, MD 20892, the Healthcare Cost and Utilization specific security measures to safeguard
301–496–9666, markowsa@nia.nih.gov. Project (HCUP),’’ System Number 09– the data from unauthorized access. HHS
This notice is being published less than 15 35–0003, is being deleted and replaced is required by law to impose, monitor,
days prior to the meeting due to the timing by this new department-wide SORN. and enforce the restrictions (see, for
limitations imposed by the review and DATES: Effective Dates: The department- example, provisions in the Confidential
funding cycle. Information Protection and Statistical
wide SORN proposed in this Notice is
Name of Committee: National Institute on effective upon publication, with the Efficiency Act of 2002 (CIPSEA), 44
Aging Special Emphasis Panel; U.S.C. 3501 at note). To impose and
Neuromuscular Interactions.
exception of the routine uses. The
Date: April 22, 2015. routine uses will be effective 30 days enforce the restrictions, it is necessary
Time: 11:00 a.m. to 3:00 p.m. after publication of this Notice, unless to collect information about the data
Agenda: To review and evaluate grant comments are received that warrant requesters.
applications. revisions to this Notice. Written Currently, this system of records
Place: National Institute on Aging, comments on the routine uses should be
mstockstill on DSK4VPTVN1PROD with NOTICES

covers data requester records in
Gateway Building, Suite 2C212, 7201 submitted within 30 days. The deletion ordering and delivery systems
Wisconsin Avenue, Bethesda, MD 20892, of System Number 09–35–0003 will be administered by three HHS Operating
(Telephone Conference Call). effective 30 days after publication of
Contact Person: Alicja L. Markowska,
Divisions, but only to the extent that the
Ph.D., DSC., Scientific Review Branch,
this Notice. records pertain to requesters seeking
National Institute on Aging, 7201 Wisconsin ADDRESSES: The public should address restricted datasets. These ordering and
Avenue, Suite 2C212, Bethesda, MD 20892, written comments to: Beth Kramer, HHS delivery systems retrieve requester
301–496–9666, markowsa@nia.nih.gov. Privacy Act Officer, Mary E. Switzer records directly by personal identifier:

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Document Created: 2015-12-18 11:04:15
Document Modified: 2015-12-18 11:04:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		April 28, 2015.
FR Citation		80 FR 17446

80 FR 17446 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 62 (April 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health