Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma, 82300-82301 [2011-33555]
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Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
srobinson on DSK4SPTVN1PROD with NOTICES
Request for Nominations of
Candidates To Serve on the Advisory
Committee on Breast Cancer in Young
Women (ACBCYW)
The CDC is soliciting nominations for
membership on the ACBCYW. The
Committee provides advice and
guidance to the Secretary, HHS; the
Assistant Secretary for Health; and the
Director, CDC, regarding the formative
research, development, implementation
and evaluation of evidence-based
activities designed to prevent breast
cancer (particularly among those at
heightened risk) and promote the early
detection and support of young women
who develop the disease. The advice
provided by the Committee will assist in
ensuring scientific quality, timeliness,
utility, and dissemination of credible
appropriate messages and resource
materials.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. The Secretary, HHS, acting
through the Director, CDC, shall appoint
to the advisory committee nominees
with expertise in breast cancer, disease
prevention, early detection, diagnosis,
public health, social marketing, genetic
screening and counseling, treatment,
rehabilitation, palliative care, and
survivorship in young women, or in
related disciplines with a specific focus
on young women. Members may be
invited to serve for up to four years. The
next cycle of selection of candidates
will begin in the winter of 2012, for
selection of potential nominees to
replace members whose terms will end
on October 15, 2012 and October 15,
2013 respectively.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of ACBCYW
objectives https://www.cdc.gov/maso/
FACM/facmACBCYW.htm. The U.S.
Department of Health and Human
Services will give close attention to
equitable geographic distribution and to
minority and female representation so
long as the effectiveness of the
Committee is not impaired.
Appointments shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientation,
HIV status, disability, and cultural,
religious, or socioeconomic status.
Nominees must be U.S. citizens, and
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19:02 Dec 29, 2011
Jkt 226001
cannot be full-time employees of the
U.S. Government.
Candidates should submit the
following items:
• Current curriculum vitae or resume,
including complete contact information
(name, affiliation, mailing address,
telephone numbers, fax number, email
address);
• A 150 word biography for the
nominee;
• At least one letter of
recommendation from a person(s) not
employed by the U.S. Department of
Health and Human Services. Candidates
may submit letter(s) from current HHS
employees if they wish, but at least one
letter must be submitted by a person not
employed by HHS.
Nominations should be submitted
(postmarked or received) by January 25,
2012.
• Electronic submission: You may
submit nominations, including
attachments, electronically to
acbcyw@cdc.gov.
• Regular, Express or Overnight Mail:
Written nominations may be submitted
to the following addressee only:
Temeika L. Fairley, Ph.D., c/o ACBCYW
Designated Federal Officer, CDC, 4770
Buford Highway NE., Mailstop K–52,
Atlanta, Georgia 30341.
Telephone and facsimile submissions
cannot be accepted. Nominations may
be submitted by the candidate or by the
person/organization recommending the
candidate.
Candidates invited to serve will be
asked to submit the ‘‘Confidential
Financial Disclosure Form for Special
Government Employees Serving on
Federal Advisory Committees at the
Centers for Disease Control and
Prevention.’’ This form allows CDC to
determine whether there is a statutory
conflict between that person’s public
responsibilities as a Special Government
Employee and private interests and
activities, or the appearance of a lack of
impartiality, as defined by Federal
regulation. The form may be viewed and
downloaded at https://www.usoge.gov/
forms/oge450_pdf/oge450_
accessible.pdf. This form should not be
submitted as part of the nomination.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and the
Agency for Toxic Substances and
Disease Registry.
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Dated: December 23, 2011.
Ronald Ergle,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2011–33576 Filed 12–29–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0827]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Revisions to
Labeling Requirements for Blood and
Blood Components, Including Source
Plasma
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
certain labeling requirements for blood
and blood components, including
Source Plasma. These requirements will
facilitate the use of a labeling system
using machine-readable information
that would be acceptable as a system for
labeling blood and blood components,
and the use of new labeling systems that
may be developed in the future.
Additionally, these requirements are
issued to help ensure the continued
safety of the blood supply and facilitate
consistency in labeling.
DATES: Submit either electronic or
written comments on the collection of
information by February 28, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://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:
Juanmanuel Vilela, Office of
SUMMARY:
E:\FR\FM\30DEN1.SGM
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Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, (301)
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
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
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. This document
solicits comments on certain labeling
requirements for blood and blood
components, including Source Plasma,
finalized as part of a rule FDA is
publishing elsewhere in this Federal
Register entitled ‘‘Revisions to Labeling
Requirements for Blood and Blood
Components, Including Source Plasma.’’
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
Revisions to Labeling Requirements for
Blood and Blood Components,
Including Source Plasma—(OMB
Control Number 0910–NEW)
FDA is finalizing the labeling
requirements for blood or blood
components intended for use in
transfusion or for further manufacture
pursuant to the provisions of the Public
Health Service Act (PHS Act) (42 U.S.C.
262–264), and the drugs, devices, and
general administrative provisions of the
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351–353, 355, 360,
360j, 371, and 374). Under these
provisions of the PHS Act and the
Federal Food, Drug, and Cosmetic Act,
we have the authority to issue and
enforce regulations designed to ensure
that biological products are safe, pure,
potent, and properly labeled, and to
prevent the introduction, transmission,
and spread of communicable disease.
Under this rulemaking, FDA is
consolidating the regulations related to
labeling blood and blood components.
Regulations for labeling of blood and
blood components will be consolidated
into § 606.121 (Container label) (21 CFR
606.121) and 21 CFR 606.122 (Circular
of information). This notice solicits
comments on the information collection
associated with § 606.121(c)(11) (21 CFR
606.121(c)(11)) which requires that if
the product is intended for further
manufacturing use, a statement listing
the results of all the tests for
communicable disease agents required
under § 610.40 (21 CFR 610.40) for
which the donation has been tested and
found negative must be on the container
label; except that the label for Source
Plasma is not required to list the
negative results of serological syphilis
testing under § 610.40(i) (21 CFR
610.40(i)) and § 640.65(b) (21 CFR
640.65(b)). In addition, this notice also
solicits comments on the information
collection associated with
§ 606.121(e)(2)(i) (21 CFR
606.121(e)(2)(i)) which requires that the
product labels of certain red blood cells
must include the type of additive
solution with which the product was
prepared.
The Agency believes the rule
amendments and the information
collection provisions under
§ 606.121(c)(11) and § 606.121(e)(2)(i) in
the final rule are part of usual and
customary business practice and do not
create any new burden for respondent.
The collection of information
requirements under §§ 606.121 and
606.122 are approved under OMB
control number 0910–0116; and those in
21 CFR 640.70 have been approved
under OMB control number 0910–0338.
Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary
to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
PO 00000
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82301
Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33555 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 30,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax:
(202) 395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0332. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Devices: Humanitarian Use
Devices—(OMB Control Number 0910–
0332)—Extension
This collection of information
implements the humanitarian use
device (HUD) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of
E:\FR\FM\30DEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82300-82301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33555]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0827]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Revisions to Labeling Requirements for Blood and Blood
Components, Including Source Plasma
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on certain labeling requirements for blood and
blood components, including Source Plasma. These requirements will
facilitate the use of a labeling system using machine-readable
information that would be acceptable as a system for labeling blood and
blood components, and the use of new labeling systems that may be
developed in the future. Additionally, these requirements are issued to
help ensure the continued safety of the blood supply and facilitate
consistency in labeling.
DATES: Submit either electronic or written comments on the collection
of information by February 28, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Juanmanuel Vilela, Office of
[[Page 82301]]
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-7651,
Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the 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 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. This document
solicits comments on certain labeling requirements for blood and blood
components, including Source Plasma, finalized as part of a rule FDA is
publishing elsewhere in this Federal Register entitled ``Revisions to
Labeling Requirements for Blood and Blood Components, Including Source
Plasma.''
Revisions to Labeling Requirements for Blood and Blood Components,
Including Source Plasma--(OMB Control Number 0910-NEW)
FDA is finalizing the labeling requirements for blood or blood
components intended for use in transfusion or for further manufacture
pursuant to the provisions of the Public Health Service Act (PHS Act)
(42 U.S.C. 262-264), and the drugs, devices, and general administrative
provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321,
331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of
the PHS Act and the Federal Food, Drug, and Cosmetic Act, we have the
authority to issue and enforce regulations designed to ensure that
biological products are safe, pure, potent, and properly labeled, and
to prevent the introduction, transmission, and spread of communicable
disease.
Under this rulemaking, FDA is consolidating the regulations related
to labeling blood and blood components. Regulations for labeling of
blood and blood components will be consolidated into Sec. 606.121
(Container label) (21 CFR 606.121) and 21 CFR 606.122 (Circular of
information). This notice solicits comments on the information
collection associated with Sec. 606.121(c)(11) (21 CFR 606.121(c)(11))
which requires that if the product is intended for further
manufacturing use, a statement listing the results of all the tests for
communicable disease agents required under Sec. 610.40 (21 CFR 610.40)
for which the donation has been tested and found negative must be on
the container label; except that the label for Source Plasma is not
required to list the negative results of serological syphilis testing
under Sec. 610.40(i) (21 CFR 610.40(i)) and Sec. 640.65(b) (21 CFR
640.65(b)). In addition, this notice also solicits comments on the
information collection associated with Sec. 606.121(e)(2)(i) (21 CFR
606.121(e)(2)(i)) which requires that the product labels of certain red
blood cells must include the type of additive solution with which the
product was prepared.
The Agency believes the rule amendments and the information
collection provisions under Sec. 606.121(c)(11) and Sec.
606.121(e)(2)(i) in the final rule are part of usual and customary
business practice and do not create any new burden for respondent.
The collection of information requirements under Sec. Sec. 606.121
and 606.122 are approved under OMB control number 0910-0116; and those
in 21 CFR 640.70 have been approved under OMB control number 0910-0338.
Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources
necessary to comply with a collection of information are excluded from
the burden estimate if the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary because they would
occur in the normal course of activities.
Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33555 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
