Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evaluation and Assessment of HRSA Teaching Health Centers, 95620-95621 [2016-31353]
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Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
phase of the regulatory review period,
while 457 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2005. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
May 25, 2005.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): July 28, 2014. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
IMLYGIC (BLA 125518) was initially
submitted on July 28, 2014.
3. The date the application was
approved: October 27, 2015. FDA has
verified the applicant’s claim that BLA
125518 was approved on October 27,
2015.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,826 days, 1,764
days, or 1400 days, respectively, of
patent term extension.
sradovich on DSK3GMQ082PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31322 Filed 12–27–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31391 Filed 12–27–16; 8:45 am]
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[Docket No. FDA–2010–N–0067]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Notice of Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Pharmaceutical Science and
Clinical Pharmacology Advisory
Committee; Notice of Meeting’’ that
appeared in the Federal Register of
November 29, 2016 (81 FR 85978). The
document announced the forthcoming
public advisory committee meeting of
the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee. The
document was published with an error
in the DATES section. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, 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:
ACPS-CP@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:
In the Federal Register of Tuesday,
November 29, 2016, in FR Doc. 2016–
28723, the following correction is made:
On page 85978, in the third column,
in the DATES section, the following
sentence is to be inserted after the first
sentence: ‘‘FDA is opening a docket for
public comment on this meeting. The
docket number is FDA–2010–N–0067.
The docket will open for public
comment on December 28, 2016. The
docket will close on April 14, 2017.’’
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Evaluation and Assessment
of HRSA Teaching Health Centers
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has
submitted an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than January 27, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluation and Assessment of HRSA
Teaching Health Centers.
OMB No. 0915–0376—Extension.
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
program supports new and the
expansion of existing primary care
residency training programs in
community-based settings. The primary
goals of the THCGME program are to
increase the production of primary care
doctors and dentists who are well
prepared to practice in community
settings, particularly with underserved
populations, and to improve the overall
number and geographic distribution of
primary care providers.
SUMMARY:
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Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Need and Proposed Use of the
Information: To ensure these goals are
achieved, the George Washington
University (GW) is conducting an
evaluation of the training,
administrative and organizational
structures, clinical service, challenges,
innovations, costs associated with
training, and outcomes of Teaching
Health Centers (THCs). GW has
developed questionnaires for
implementation with all THC
matriculating residents, graduating
residents, and graduated residents at
one year post-graduation. The
matriculation questionnaire aims to
collect background information on THC
residents to better understand the
characteristics of individuals who apply
and are accepted to THC programs. The
graduation questionnaire collects
information on career plans. The alumni
questionnaire collects information on
career outcomes (including practice in
primary care and in underserved
settings) following graduation as well as
feedback on the quality of training.
Statute requires that THCGME
program award recipients report
annually on the types of primary care
resident approved training programs
provided, the number of approved
training positions, the number who
completed their residency at the end of
the prior academic year and care for
vulnerable populations living in
underserved areas, and any other
information as deemed appropriate by
the Secretary. The described data
collection activities will serve to meet
this statutory requirement for the
THCGME program award recipients in a
uniform and consistent manner and will
allow comparisons of this group to other
trainees in non-THC programs. HRSA
seeks renewal of these measures with no
changes.
Likely Respondents: This data
collection includes documents that are
completed separately by THC Program
Directors and residents. THC Program
Directors who have not already
completed the program data collection
tool will respond to the part of the data
collection tool related to the
characteristics of the programs. Annual
updates are made on an as-needed basis.
THC matriculating residents, graduating
residents and graduated residents at one
year post-graduation will respond to the
questionnaires related to characteristics
of the residents.
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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden
per
response
(in hours)
Total
burden
hours
Program Data Collection Tool .............................................
THC Alumni Survey .............................................................
THC Matriculant Survey .......................................................
THC Graduation Survey ......................................................
10
200
200
200
1
1
1
1
10
200
200
200
8
0.33
0.25
0.25
80
66
50
50
Total ..............................................................................
610
........................
610
........................
246
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–31353 Filed 12–27–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Small Health Care
Provider Quality Improvement Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
SUMMARY:
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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.
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.
ADDRESSES:
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When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Small Health Care Provider Quality
Improvement Program
OMB No. 0915–0387—Extension
Abstract: This program is authorized
by Title III, Public Health Service Act,
Section 330A(g) (42 U.S.C. 254c(g)), as
amended by Section 201, P.L. 107–251,
and Section 4, P.L. 110–355. This
authority directs the Federal Office of
Rural Health Policy (FORHP) to support
grants that expand access to, coordinate,
contain the cost of, and improve the
quality of essential health care services,
including preventive and emergency
services, through the development of
health care networks in rural and
frontier areas and regions. Across these
various programs, the authority allows
HRSA to provide funds to rural and
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95620-95621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31353]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Evaluation and Assessment
of HRSA Teaching Health Centers
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has submitted an Information Collection
Request (ICR) to the Office of Management and Budget (OMB) for review
and approval. Comments submitted during the first public review of this
ICR will be provided to OMB. OMB will accept further comments from the
public during the review and approval period.
DATES: Comments on this ICR should be received no later than January
27, 2017.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: Information Collection Request Title:
Evaluation and Assessment of HRSA Teaching Health Centers.
OMB No. 0915-0376--Extension.
Abstract: The Teaching Health Center Graduate Medical Education
(THCGME) program supports new and the expansion of existing primary
care residency training programs in community-based settings. The
primary goals of the THCGME program are to increase the production of
primary care doctors and dentists who are well prepared to practice in
community settings, particularly with underserved populations, and to
improve the overall number and geographic distribution of primary care
providers.
[[Page 95621]]
Need and Proposed Use of the Information: To ensure these goals are
achieved, the George Washington University (GW) is conducting an
evaluation of the training, administrative and organizational
structures, clinical service, challenges, innovations, costs associated
with training, and outcomes of Teaching Health Centers (THCs). GW has
developed questionnaires for implementation with all THC matriculating
residents, graduating residents, and graduated residents at one year
post-graduation. The matriculation questionnaire aims to collect
background information on THC residents to better understand the
characteristics of individuals who apply and are accepted to THC
programs. The graduation questionnaire collects information on career
plans. The alumni questionnaire collects information on career outcomes
(including practice in primary care and in underserved settings)
following graduation as well as feedback on the quality of training.
Statute requires that THCGME program award recipients report
annually on the types of primary care resident approved training
programs provided, the number of approved training positions, the
number who completed their residency at the end of the prior academic
year and care for vulnerable populations living in underserved areas,
and any other information as deemed appropriate by the Secretary. The
described data collection activities will serve to meet this statutory
requirement for the THCGME program award recipients in a uniform and
consistent manner and will allow comparisons of this group to other
trainees in non-THC programs. HRSA seeks renewal of these measures with
no changes.
Likely Respondents: This data collection includes documents that
are completed separately by THC Program Directors and residents. THC
Program Directors who have not already completed the program data
collection tool will respond to the part of the data collection tool
related to the characteristics of the programs. Annual updates are made
on an as-needed basis. THC matriculating residents, graduating
residents and graduated residents at one year post-graduation will
respond to the questionnaires related to characteristics of the
residents.
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 ICR 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)
----------------------------------------------------------------------------------------------------------------
Program Data Collection Tool.... 10 1 10 8 80
THC Alumni Survey............... 200 1 200 0.33 66
THC Matriculant Survey.......... 200 1 200 0.25 50
THC Graduation Survey........... 200 1 200 0.25 50
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Total....................... 610 .............. 610 .............. 246
----------------------------------------------------------------------------------------------------------------
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-31353 Filed 12-27-16; 8:45 am]
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