Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau and Bureau of Health Workforce Research and Training Grants, 95147-95148 [2016-31080]
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Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Psychopharmacologic
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on
February 16, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: College Park Marriott Hotel
and Conference Center, 3501 University
Blvd. East, Hyattsville, MD 20783. The
conference center’s telephone number is
301–985–7300. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
SUMMARY:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, 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, Fax: 301–847–8533, email:
PDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
new drug application (NDA) 209241,
Valbenazine 40 milligram (mg) capsules,
for the proposed treatment of Tardive
VerDate Sep<11>2014
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Dyskinesia, submitted by Neurocrine
Biosciences, Inc.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 2, 2017.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before January
25, 2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by January 26, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kalyani Bhatt
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
PO 00000
Frm 00050
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95147
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31144 Filed 12–23–16; 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; Forms for Use With
Applications to the Maternal and Child
Health Bureau and Bureau of Health
Workforce Research and Training
Grants
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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),
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 ICR must be
received no later than February 27,
2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 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.
Information Collection Request Title:
Forms for Use with Applications to the
Maternal and Child Health Bureau and
Bureau of Health Workforce Research
and Training Grants OMB No. 0906–
xxxx—New
SUMMARY:
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95148
Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices
Abstract: Currently HRSA is cleared
to use the National Institutes of Health’s
(NIH) Biographical Sketch and Public
Health Service (PHS) Inclusion
Enrollment forms (0925–0001) for
HRSA’s SF424 Research & Related
(R&R) application package research
grants. However, both of these
documents contain NIH-specific
references. To use the forms, HRSA
plans to remove the NIH-specific
references and obtain its own OMB
control number for the collection of this
information.
The current Statement of
Appointment (form PHS–2271) is also
tailored to NIH programs. HRSA plans
to remove references to NIH and where
appropriate replace them with
references to HRSA for use in the SF424
R&R application package.
Need and Proposed Use of the
Information: Currently, there are two
Bureaus within HRSA, the Maternal and
Child Health Bureau (MCHB) and the
Bureau of Health Workforce (BHW), that
use the Biographical Sketch. In addition
to the Biographical Sketch, MCHB also
uses the PHS Inclusion Enrollment
form, and BHW uses the Statement of
Appointment form as required elements
of the SF424 Research & Related
application package. These Bureaus
plan to modify these forms in slightly
different ways to meet the needs of their
own research and training grant
programs.
In MCHB’s research grant programs,
the modified Biographical Sketch form
will be used by applicants to summarize
the qualifications of key personnel on
their proposed research team; the grant
reviewers will use this information to
assess the capabilities of the research
team to carry out the research project.
MCHB’s modified PHS Inclusion
Enrollment form will be used by
applicants to summarize their expected
population of research study
participants at the time of submission of
their proposal; it will also be used for
Enrollment Reporting during the annual
Noncompeting Continuation Award.
Monitoring Inclusion Enrollment is one
important component of ensuring
statistically meaningful demographics
(race, ethnicity, and gender) among
research study participants in MCHB’s
research grant portfolio. MCHB does not
use the Statement of Appointment form,
as it does not pertain to the MCHB
research program.
Similarly, in BHW the modified
Biographical Sketch form will be used
by applicants to summarize the
qualifications of key personnel
proposed as project staff; the grant
reviewers will use this information to
assess the capabilities of the applicant
organization to carry out the proposed
project. The modified Statement of
Appointment form is used to document
the appointment of individuals
supported by the award to applicable
institutional research and training
programs. BHW does not use the PHS
Inclusion Enrollment form, as it does
not pertain to the BHW training and
research programs.
Likely Respondents: Respondents are
applicants to HRSA’s research programs
in MCHB and research and training
programs in BHW.
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 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
Total ..............................................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Biographical Sketch for MCHB research grant applicants ..
PHS Inclusion Enrollment form for MCHB research grant
applications .......................................................................
Biographical Sketch for BHW training and research grant
applicants .........................................................................
Statement of Appointment form for BHW training grantees
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.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–31080 Filed 12–23–16; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014
20:45 Dec 23, 2016
Jkt 241001
Number of
responses per
respondent
Total burden
hours
5
1000
2
2000
200
1
200
.5
100
1000
800
5
7
5000
5600
2
.5
10,000
2,800
2200
........................
11,800
........................
14,900
Health Resources and Services
Administration
Updating the HRSA-Supported
Women’s Preventive Services
Guidelines
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
Effective December 20, 2016,
the Health Resources and Services
Administration (HRSA) updated the
HRSA-supported Women’s Preventive
SUMMARY:
Frm 00051
Average
burden per
response
(in hours)
200
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Total
responses
Fmt 4703
Sfmt 4703
Services Guidelines for purposes of
health insurance coverage for preventive
services that address health needs
specific to women based on clinical
recommendations from the Women’s
Preventive Services Initiative. This
notice serves as an announcement of the
decision to update the guidelines as
listed below. Please see https://
www.hrsa.gov/womensguidelines2016
for additional information.
FOR FURTHER INFORMATION CONTACT:
HRSA, Maternal and Child Health
Bureau at email: wellwomancare@
hrsa.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95147-95148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31080]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Forms for Use With Applications to the Maternal
and Child Health Bureau and Bureau of Health Workforce Research and
Training Grants
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
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), 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 ICR must be received no later than February 27,
2017.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N-39, 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.
Information Collection Request Title: Forms for Use with
Applications to the Maternal and Child Health Bureau and Bureau of
Health Workforce Research and Training Grants OMB No. 0906-xxxx--New
[[Page 95148]]
Abstract: Currently HRSA is cleared to use the National Institutes
of Health's (NIH) Biographical Sketch and Public Health Service (PHS)
Inclusion Enrollment forms (0925-0001) for HRSA's SF424 Research &
Related (R&R) application package research grants. However, both of
these documents contain NIH-specific references. To use the forms, HRSA
plans to remove the NIH-specific references and obtain its own OMB
control number for the collection of this information.
The current Statement of Appointment (form PHS-2271) is also
tailored to NIH programs. HRSA plans to remove references to NIH and
where appropriate replace them with references to HRSA for use in the
SF424 R&R application package.
Need and Proposed Use of the Information: Currently, there are two
Bureaus within HRSA, the Maternal and Child Health Bureau (MCHB) and
the Bureau of Health Workforce (BHW), that use the Biographical Sketch.
In addition to the Biographical Sketch, MCHB also uses the PHS
Inclusion Enrollment form, and BHW uses the Statement of Appointment
form as required elements of the SF424 Research & Related application
package. These Bureaus plan to modify these forms in slightly different
ways to meet the needs of their own research and training grant
programs.
In MCHB's research grant programs, the modified Biographical Sketch
form will be used by applicants to summarize the qualifications of key
personnel on their proposed research team; the grant reviewers will use
this information to assess the capabilities of the research team to
carry out the research project. MCHB's modified PHS Inclusion
Enrollment form will be used by applicants to summarize their expected
population of research study participants at the time of submission of
their proposal; it will also be used for Enrollment Reporting during
the annual Noncompeting Continuation Award. Monitoring Inclusion
Enrollment is one important component of ensuring statistically
meaningful demographics (race, ethnicity, and gender) among research
study participants in MCHB's research grant portfolio. MCHB does not
use the Statement of Appointment form, as it does not pertain to the
MCHB research program.
Similarly, in BHW the modified Biographical Sketch form will be
used by applicants to summarize the qualifications of key personnel
proposed as project staff; the grant reviewers will use this
information to assess the capabilities of the applicant organization to
carry out the proposed project. The modified Statement of Appointment
form is used to document the appointment of individuals supported by
the award to applicable institutional research and training programs.
BHW does not use the PHS Inclusion Enrollment form, as it does not
pertain to the BHW training and research programs.
Likely Respondents: Respondents are applicants to HRSA's research
programs in MCHB and research and training programs in BHW.
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 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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Biographical Sketch for MCHB 200 5 1000 2 2000
research grant applicants......
PHS Inclusion Enrollment form 200 1 200 .5 100
for MCHB research grant
applications...................
Biographical Sketch for BHW 1000 5 5000 2 10,000
training and research grant
applicants.....................
Statement of Appointment form 800 7 5600 .5 2,800
for BHW training grantees......
-------------------------------------------------------------------------------
Total....................... 2200 .............. 11,800 .............. 14,900
----------------------------------------------------------------------------------------------------------------
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.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-31080 Filed 12-23-16; 8:45 am]
BILLING CODE 4165-15-P
