National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 17446-17447 [2015-07343]
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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
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1 There
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
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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).
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.
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
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.
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
(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;
Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07420 Filed 3–31–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
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Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
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.
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. 2015–07343 Filed 3–31–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–07339 Filed 3–31–15; 8:45 am]
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National Institute on Aging; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Privacy Act of 1974; System of
Records Notice
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.
AGENCY:
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
SUMMARY:
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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.
Beth
Kramer, HHS Privacy Act Officer, Mary
E. Switzer Building—Room 2210, 330 C
Street SW., Washington, DC 20201,
beth.kramer@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
SUPPLEMENTARY INFORMATION:
National Institutes of Health
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Agencies
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17446-17447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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, 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;
[[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