Agency Information Collection Activities: Proposed Collection: Public Comment Request, 27452-27453 [2016-10635]
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27452
Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
that is required for submissions to the
SRDP and providing a streamlined and
standardized format for the presentation
of the required information. Form
Number: CMS–10328 (OMB control
number: 0938–1106); Frequency:
Annually and semi-annually; Affected
Public: Private sector (Business or other
for-profits and Not-for-profits); Number
of Respondents: 200; Total Annual
Responses: 200; Total Annual Hours:
5,000. (For policy questions regarding
this collection contact Matt Edgar at
410–786–0698.)
Dated: May 3, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–10705 Filed 5–5–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1687]
Advisory Committee; Pharmacy
Compounding Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pharmacy Compounding
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Pharmacy
Compounding Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 25, 2018.
DATES: Authority for the Pharmacy
Compounding Advisory Committee will
expire on April 25, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
PCAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Pharmacy Compounding Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Pharmacy
Compounding Advisory Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to compounded drugs for human
use and, as required, any other product
for which the Food and Drug
Administration has regulatory
responsibility.
The Committee shall provide advice
on scientific, technical, and medical
issues concerning drug compounding
under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a) and (21 U.S.C. 353b),
and, as required, any other product for
which the Food and Drug
Administration has regulatory
responsibility, and make appropriate
recommendations to the Commissioner
of Food and Drugs.
The Committee shall consist of a core
of 12 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. 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
core of voting members may include one
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
members who are identified with
industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PharmacyCompoundingAdvisory
Committee/ucm381305.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
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CONTACT).
In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: April 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–10585 Filed 5–5–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than July 5, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
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27453
Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
Information Collection Request Title:
Data Use Agreement and Supplement
for 2014 Health Center Patient Survey.
OMB No.: 0915–xxxx–New.
Abstract: The Health Center Patient
Survey (HCPS), sponsored by the Health
Resources and Services
Administration’s (HRSA) Bureau of
Primary Health Care (BPHC), surveys
patients who use health centers funded
under Section 330 of the Public Health
Service Act. HCPS collects data on
health center patients’
sociodemographic characteristics,
health conditions, health behaviors,
access to and utilization of health care
services, and satisfaction with their
health care. Survey results come from
in-person, one-on-one interviews with
patients and are nationally
representative of the Health Center
Program patient population. To inform
BPHC and HHS policy, funding, and
planning decisions, the survey
investigated how well HRSA-supported
sites meet health care needs of the
medically underserved and assessed
how patients perceive the quality of
their care. HCPS is unique because it
focused on comprehensive patient-level
data. These and other features of the
data will provide researchers and
policymakers the capacity to
empirically explore policy topics
relevant to the Health Center Program
using up-to-date information.
Prior to releasing information from
the survey, BPHC will request
prospective users to complete the ‘‘Data
Use Agreement’’ (DUA). BPHC uses
DUAs as legal binding agreements when
an external entity (e.g., contractor,
private industry, academic institution,
other federal government agency, or
state agency) requests the use of BPHC
personally/organizationally identifiable
data that is covered by the Privacy Act
of 1974. The agreement delineates the
confidentiality requirements of the
Privacy Act, security safeguards, and
BPHC’s data use policies and
procedures. The DUA will serve as both
a means of informing data users of these
requirements and a means of obtaining
their agreement to abide by these
requirements.
Need and Proposed Use of the
Information: Before allowing access to
unrestricted data that contains sensitive
grantee and patient information that is
protected by the Privacy Act of 1974,
prospective users will submit a signed
DUA and describe what proposed
research they intend to undertake in
using the dataset. A BPHC workgroup
will determine whether the project is an
appropriate and legitimate use of the
data. The criteria to determine
admissible projects will include: (1)
Relevance of the topic of study to
BPHC/HHS policy; (2) feasibility of the
project given the parameters described
in DUA supplemental; and (3) the
proposed end-use of the research that
will be undertaken.
Likely Respondents: Prospective
researchers in academia, private
contractors, and Primary Care
Associations/Health Center Program
grantee organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
DUA ......................................................................................
DUA Supplemental ..............................................................
20
20
1
1
20
20
0.25
1.25
5
25
Total ..............................................................................
40
........................
40
........................
30
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–10635 Filed 5–5–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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
PO 00000
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applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neurogenesis and Cell Fate
Study Section.
Date: June 1, 2016.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Crystal City, 2799
Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Joanne T Fujii, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184,
MSC 7850, Bethesda, MD 20892, (301) 435–
1178, fujiij@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
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[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Pages 27452-27453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10635]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than July 5, 2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N-39, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 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
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
[[Page 27453]]
Information Collection Request Title: Data Use Agreement and
Supplement for 2014 Health Center Patient Survey.
OMB No.: 0915-xxxx-New.
Abstract: The Health Center Patient Survey (HCPS), sponsored by the
Health Resources and Services Administration's (HRSA) Bureau of Primary
Health Care (BPHC), surveys patients who use health centers funded
under Section 330 of the Public Health Service Act. HCPS collects data
on health center patients' sociodemographic characteristics, health
conditions, health behaviors, access to and utilization of health care
services, and satisfaction with their health care. Survey results come
from in-person, one-on-one interviews with patients and are nationally
representative of the Health Center Program patient population. To
inform BPHC and HHS policy, funding, and planning decisions, the survey
investigated how well HRSA-supported sites meet health care needs of
the medically underserved and assessed how patients perceive the
quality of their care. HCPS is unique because it focused on
comprehensive patient-level data. These and other features of the data
will provide researchers and policymakers the capacity to empirically
explore policy topics relevant to the Health Center Program using up-
to-date information.
Prior to releasing information from the survey, BPHC will request
prospective users to complete the ``Data Use Agreement'' (DUA). BPHC
uses DUAs as legal binding agreements when an external entity (e.g.,
contractor, private industry, academic institution, other federal
government agency, or state agency) requests the use of BPHC
personally/organizationally identifiable data that is covered by the
Privacy Act of 1974. The agreement delineates the confidentiality
requirements of the Privacy Act, security safeguards, and BPHC's data
use policies and procedures. The DUA will serve as both a means of
informing data users of these requirements and a means of obtaining
their agreement to abide by these requirements.
Need and Proposed Use of the Information: Before allowing access to
unrestricted data that contains sensitive grantee and patient
information that is protected by the Privacy Act of 1974, prospective
users will submit a signed DUA and describe what proposed research they
intend to undertake in using the dataset. A BPHC workgroup will
determine whether the project is an appropriate and legitimate use of
the data. The criteria to determine admissible projects will include:
(1) Relevance of the topic of study to BPHC/HHS policy; (2) feasibility
of the project given the parameters described in DUA supplemental; and
(3) the proposed end-use of the research that will be undertaken.
Likely Respondents: Prospective researchers in academia, private
contractors, and Primary Care Associations/Health Center Program
grantee organizations.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
DUA............................. 20 1 20 0.25 5
DUA Supplemental................ 20 1 20 1.25 25
-------------------------------------------------------------------------------
Total....................... 40 .............. 40 .............. 30
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-10635 Filed 5-5-16; 8:45 am]
BILLING CODE 4165-15-P
