Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 61824-61825 [2015-26058]
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61824
Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
In the Federal Register of April 10,
2008 (73 FR 19511), FDA announced the
availability of the April 2008 Guidance.
In that guidance, FDA provided
sponsors of a human gene therapy IND,
including those with combination
products that contain a human gene
therapy biological product with a drug
or device as part of the final product,
with recommendations on CMC
information that is to be included in an
original IND. That guidance also
provided instruction to FDA CMC
reviewers about the information to
record and assess as part of an IND
review. The draft guidance, when
finalized, will supplement the April
2008 Guidance.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on
recommendations for MVGTs. It does
not establish any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirement of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 211, 610,
and 312 have been approved under
OMB control numbers 0910–0139 and
0910–0114, respectively.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26108 Filed 10–13–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Committee on Training in
Primary Care Medicine and Dentistry;
Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Council on Graduate Medical
Education (COGME).
Dates and Times: October 29, 2015
(10:30 a.m.–4:30 p.m.).
Place: Conference Call/Webinar
Format.
Status: The meeting will be open to
the public.
Purpose: The COGME provides advice
and recommendations to the Secretary
of the Department of Health and Human
Services (the Secretary) on a range of
issues including the supply and
distribution of physicians in the United
States, current and future physician
shortages or excesses, issues relating to
foreign medical school graduates, the
nature and financing of medical
education training, and the
development of performance measures
and longitudinal evaluation of medical
education programs. COGME’s reports
are submitted to the Secretary and
ranking members of the Senate
Committee on Health, Education, Labor,
and Pensions and the House of
Representatives Committee on Energy
and Commerce.
HRSA will conduct an orientation for
new members prior to the start of the
meeting. COGME will start its official
meeting at 10:30 a.m. After the
orientation, discussion will focus on
one of the recommendations from the
March 2015 meeting, namely, to identify
actions COGME can take within its
current authorities to achieve the
development of a National Strategic
Plan for Graduate Medical Education.
Agenda: The COGME agenda will be
available 2 days prior to the meeting on
the HRSA Web site at https://
www.hrsa.gov/advisorycommittees/
bhpradvisory/cogme/.
SUPPLEMENTARY INFORMATION: Requests
to make oral comments or provide
written comments to the COGME should
be sent to Dr. Joan Weiss, Designated
Federal Official, using the address and
phone number below. Individuals who
plan to participate on the conference
call and webinar should notify Dr.
Weiss at least 3 days prior to the
meeting, using the address and phone
number below. Members of the public
PO 00000
Frm 00035
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will have the opportunity to provide
comments. Interested parties should
refer to the meeting subject as the HRSA
Council on Graduate Medical
Education.
• The conference call-in number is 1–
800–619–2521. The passcode is:
9271697.
• The webinar link is https://
hrsa.connectsolutions.com/
cogme-2015/.
Contact: Anyone requesting
information regarding the COGME
should contact Dr. Joan Weiss,
Designated Federal Official within the
Bureau of Health Workforce, Health
Resources and Services Administration,
in one of three ways: (1) Send a request
to the following address: Dr. Joan Weiss,
Designated Federal Official, Bureau of
Health Workforce, Health Resources and
Services Administration, Parklawn
Building, Room 12C–05, 5600 Fishers
Lane, Rockville, Maryland 20857; (2)
call (301) 443–0430; or (3) send an email
to jweiss@hrsa.gov.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–26053 Filed 10–13–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–New–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for a
new collection. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before November 13,
2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
SUMMARY:
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61825
Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
0990–New–30D for reference.
Information Collection Request Title:
State and Territorial Health Disparities
Survey Abstract: The Office of Minority
Health (OMH), Office of the Secretary
(OS) is requesting approval from the
Office of Management and Budget
(OMB) for a new data collection activity
for the State and Territorial Health
Disparities Survey (STHD Survey).
OMH has a long history of
collaborating with states to improve
minority health outcomes and reduce
health and health care disparities. A
strong partnership with state and
territorial offices is a key to continue
progress toward eliminating health
disparities. To best facilitate continued
partnerships, OMH needs information
about the current activities, challenges,
and resources within state and
territorial offices of minority health. The
State and Territorial Health Disparities
Survey is intended to support OMH
informational needs by collecting,
organizing, and presenting a variety of
information about states and U.S.
territories, including the current status
of minority health and health
disparities, the organization and
operation of state and territorial offices
of minority health, and state/territorial
implementation of federal standards and
evidence-based practices designed to
address disparities and improve
minority health. The STHD Survey,
which will focus on the activities,
staffing, and funding of State Minority
Health Entities, is part of a larger project
to catalog the extent of health disparities
and the activities underway to reduce
them in each state and U.S. territory.
The STHD Survey supports OMH’s
goals of working with states and
territories to improve the health of racial
Number of
respondents
Form Name
and ethnic minority populations and
eliminate health disparities. While
existing, state/territorial-specific
information sources (e.g., quantitative
data points available from the Agency
for Healthcare Research and Quality’s
National Healthcare Disparities Report
State Snapshots) offer important facts
about the status of health disparities,
they do not provide context around the
efforts underway to reduce them. Likely
Respondents—Data will be collected
using semi-structured telephone
interviews with state/territorial minority
health entity directors (or their
designees) in approximately 54 states
and territories (50 states plus the
District of Columbia and the U.S.
territories of Guam, Puerto Rico, and the
U.S. Virgin Islands). The purpose of this
interview is to collect qualitative
information about state/territory
program goals and activities,
partnerships, and organizational
structure, as well as quantitative data
elements on staffing and funding.
Number of
responses per
respondents
Average
hours per
response
Total burden
hours
State and Territorial Survey .............................................................................
54
1
1.5
81
Total .................................................................................................................
54
........................
........................
81
Darius Taylor,
Information Collection Clearance Officer.
number 0937–0166, scheduled to expire
on October 31, 2015. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before November 13,
2015.
[FR Doc. 2015–26058 Filed 10–13–15; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0937–0166]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:39 Oct 13, 2015
Jkt 238001
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 0937–0166 for
reference.
Information Collection Request Title:
HHS 42 CFR part 50, subpart B;
Sterilization of Persons in Federally
Assisted Family Planning Projects—
OMB No. 0937–0166–Extension–OASH,
Office of Population Affairs—Office of
Family Planning.
ADDRESSES:
PO 00000
Frm 00036
Fmt 4703
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Abstract: This is a request for
extension of a currently approved
collection for the disclosure and recordkeeping requirements codified at 42
CFR part 50, subpart B (‘‘Sterilization of
Persons in Federally Assisted Family
Planning Projects’’). The consent form
solicits information to assure voluntary
and informed consent to persons
undergoing sterilization in programs of
health services which are supported by
federal financial assistance
administered by the Public Health
Service (PHS). Consent forms are signed
by individuals undergoing a federally
funded sterilization procedure and
certified by necessary medical
authorities. Forms are incorporated into
the patient’s medical records and the
agency’s records. Through periodic site
audits and visits, PHS staff review
completed consent forms to determine
compliance with the regulation. Thus,
the purpose of the consent form is
twofold. First, it serves as a mechanism
to ensure that a person receives
information about sterilization and
voluntarily consents to the procedure.
Second, it facilitates compliance
monitoring. The Sterilization Consent
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[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61824-61825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-New-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for a new collection.
Comments submitted during the first public review of this ICR will be
provided to OMB. OMB will accept further comments from the public on
this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before November 13,
2015.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
[[Page 61825]]
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the Information Collection Request Title
and document identifier HHS-OS-0990-New-30D for reference.
Information Collection Request Title: State and Territorial Health
Disparities Survey Abstract: The Office of Minority Health (OMH),
Office of the Secretary (OS) is requesting approval from the Office of
Management and Budget (OMB) for a new data collection activity for the
State and Territorial Health Disparities Survey (STHD Survey).
OMH has a long history of collaborating with states to improve
minority health outcomes and reduce health and health care disparities.
A strong partnership with state and territorial offices is a key to
continue progress toward eliminating health disparities. To best
facilitate continued partnerships, OMH needs information about the
current activities, challenges, and resources within state and
territorial offices of minority health. The State and Territorial
Health Disparities Survey is intended to support OMH informational
needs by collecting, organizing, and presenting a variety of
information about states and U.S. territories, including the current
status of minority health and health disparities, the organization and
operation of state and territorial offices of minority health, and
state/territorial implementation of federal standards and evidence-
based practices designed to address disparities and improve minority
health. The STHD Survey, which will focus on the activities, staffing,
and funding of State Minority Health Entities, is part of a larger
project to catalog the extent of health disparities and the activities
underway to reduce them in each state and U.S. territory. The STHD
Survey supports OMH's goals of working with states and territories to
improve the health of racial and ethnic minority populations and
eliminate health disparities. While existing, state/territorial-
specific information sources (e.g., quantitative data points available
from the Agency for Healthcare Research and Quality's National
Healthcare Disparities Report State Snapshots) offer important facts
about the status of health disparities, they do not provide context
around the efforts underway to reduce them. Likely Respondents--Data
will be collected using semi-structured telephone interviews with
state/territorial minority health entity directors (or their designees)
in approximately 54 states and territories (50 states plus the District
of Columbia and the U.S. territories of Guam, Puerto Rico, and the U.S.
Virgin Islands). The purpose of this interview is to collect
qualitative information about state/territory program goals and
activities, partnerships, and organizational structure, as well as
quantitative data elements on staffing and funding.
----------------------------------------------------------------------------------------------------------------
Number of
Form Name Number of responses per Average hours Total burden
respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
State and Territorial Survey.................... 54 1 1.5 81
---------------------------------------------------------------
Total........................................... 54 .............. .............. 81
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-26058 Filed 10-13-15; 8:45 am]
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