Agency Information Collection Activities; Proposed Collection: Comment Request, 61007-61008 [2012-24626]
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Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–24560 Filed 10–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Tobacco Products Scientific
Advisory Committee, Office of Science,
Center for Tobacco Products.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before December 4, 2012, will be given
first consideration for membership on
the Tobacco Products Scientific
Advisory Committee. Nominations
received after December 4, 2012, will be
considered for nomination to the
committee as later vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically to cv@oc.fda.gov or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Caryn Cohen, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose Option 4), FAX: 240–276–3655,
TPSAC@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
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members on the Tobacco Products
Scientific Advisory Committee.
Elsewhere in this issue of the Federal
Register, FDA is publishing a separate
document announcing the Request for
Notification for Nonvoting Members on
the Tobacco Products Scientific
Advisory Committee.
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee advises the
Commissioner of Food and Drugs (the
Commissioner) or designee in
discharging responsibilities as they
relate to the regulation of tobacco
products. The Committee reviews and
evaluates safety, dependence, and
health issues relating to tobacco
products and provides appropriate
advice, information and
recommendations to the Commissioner.
II. Criteria for Voting Members
The Committee shall consist of 12
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
individuals knowledgeable in the fields
of medicine, medical ethics, science, or
technology involving the manufacture,
evaluation, or use of tobacco products.
Members will be invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The Committee shall
include nine technically qualified
voting members, selected by the
Commissioner or designee. The nine
voting members shall be physicians,
dentists, scientists, or health care
professionals practicing in the area of
oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or
any other relevant specialty.
In addition to the voting members, the
committee shall include three nonvoting
members who are identified with
industry interests. These members shall
include one representative of the
tobacco manufacturing industry, one
representative of the interests of tobacco
growers, and one representative of the
interests of the small business tobacco
manufacturing industry.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
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61007
specify the advisory committee for
which the nominee is recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–24476 Filed 10–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: HRSA National
Environmental Policy Act (NEPA)
Environmental Information and
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61008
Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Documentation (EID) (OMB No. 0915–
0324) Revision.
HRSA is requesting extension of the
approval for the Environmental
Information and Documentation (EID)
checklist which consists of information
that the agency is required to obtain to
comply with the National
Environmental Policy Act of 1969
(NEPA). NEPA establishes the federal
government’s national policy for
protection of the environment. HRSA
has developed the EID for applicants of
funding that would potentially impact
Number of
respondents
Instrument
Responses
per
respondent
the environment and to ensure that their
decision-making processes are
consistent with NEPA. Applicants must
provide information and assurance of
compliance with NEPA on the EID
checklist. The estimated annual burden
is as follows:
Total
responses
Hours per
response
Total burden
hours
NEPA EID Checklist ............................................................
2,734
1
2,734
1
2,734
Total ..............................................................................
2,734
1
2,734
1
2,734
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: October 2, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–24626 Filed 10–4–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Comments Under the
Paperwork Reduction Act, Section
3506
National Institutes of Health
(NIH), HHS.
ACTION: Request for comments.
AGENCY:
The National Institutes of
Health (NIH), as part of its continuing
effort to reduce paperwork and
respondent burden, invites the general
public and other Federal agencies to
take this opportunity to comment on
proposed and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995,
Section 3506.
Proposed Collection: Title: National
Institutes of Health Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes;
Type of Information Collection Request:
New; Need and Use of Information
Collection: The NIH mission is to seek
fundamental knowledge about the
nature and behavior of living systems
and the application of that knowledge to
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enhance health, lengthen life, and
reduce the burdens of illness and
disability. The sharing of research data
supports this mission and is essential to
facilitate the translation of research
results into knowledge, products,
practices, and procedures that improve
human health.
By enabling secondary research
questions to be addressed, data sharing
maximizes the public benefit achieved
through research investments. NIH’s
Policy for Sharing of Data Obtained in
NIH Supported or Conducted GenomeWide Association Studies (GWAS) was
established to enable the full value of
GWAS data to be realized. GWAS data
are maintained in a central data
repository, the database of Genotypes
and Phenotypes (dbGaP), which is
administered by the National Center for
Biotechnology Information (NCBI), part
of the National Library of Medicine at
NIH.
As stipulated in the NIH GWAS
policy, all principal investigators (PIs)
who receive NIH funding to conduct
genomic research are expected to
register studies with genomic data in
dbGaP. The nature of the genomic,
phenotypic, and other associated data
generated through large-scale human
genomic studies requires responsible
stewardship throughout research and
data sharing activities. Since the data
being collected and shared are from
human research participants, the
protection of participant interests is
paramount. PIs submitting data to
dbGaP must describe any limitations on
sharing the data, as defined in the
informed consent provided by the
participants from whom the data were
originally collected. PIs must also
provide basic study information such as
the type of data that will be submitted
to dbGaP and a description of the study.
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Researchers interested in using dbGaP
data for secondary research must submit
a request through dbGaP and be granted
permission from the relevant NIH Data
Access Committees to access the data.
As part of the request process,
researchers must provide information
such as a description of the proposed
research use of the dbGaP datasets, a
data security plan, and a Data Use
Certification, in which the researcher
agrees to the terms and conditions for
use of the data. NIH has developed
online forms, which will be available
through dbGaP, in an effort to reduce
the burden for researchers to complete
the study registration, data submission,
and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and
senior officials from their institutions.
Estimate of Burden: The burden
associated with this information
collection is calculated in two parts: (1)
The burden associated with registering
genomic studies and submitting data to
dbGaP and (2) the burden associated
with applying for genomic data in
dbGaP. The annual reporting burden for
study registration and data submission
is as follows: Estimated Number of
Respondents: 100; Estimated Number of
Responses per Respondent: 1; and
Estimated Total Annual Burden Hours
Requested: 63. The annual cost to
respondents is estimated at $2,506. The
annual reporting burden for applying for
genomic data in dbGaP is as follows:
Estimated Number of Respondents:
1,266; Estimated Number of Responses
per Respondent: 2; and Estimated Total
Annual Burden Hours Requested: 1,583.
The annual cost to respondents is
estimated at $63,452. There are no
capital, operating, or maintenance costs
to the respondents.
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]]>Agencies
[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61007-61008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24626]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: HRSA National Environmental Policy Act (NEPA)
Environmental Information and
[[Page 61008]]
Documentation (EID) (OMB No. 0915-0324) Revision.
HRSA is requesting extension of the approval for the Environmental
Information and Documentation (EID) checklist which consists of
information that the agency is required to obtain to comply with the
National Environmental Policy Act of 1969 (NEPA). NEPA establishes the
federal government's national policy for protection of the environment.
HRSA has developed the EID for applicants of funding that would
potentially impact the environment and to ensure that their decision-
making processes are consistent with NEPA. Applicants must provide
information and assurance of compliance with NEPA on the EID checklist.
The estimated annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
NEPA EID Checklist.............. 2,734 1 2,734 1 2,734
-------------------------------------------------------------------------------
Total....................... 2,734 1 2,734 1 2,734
----------------------------------------------------------------------------------------------------------------
Email comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: October 2, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-24626 Filed 10-4-12; 8:45 am]
BILLING CODE 4165-15-P
