Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows, 52439-52440 [2016-18711]
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
review and clearance. The Federal
Register notice that solicited public
comment on the information collection
for a period of 60 days was published
on March 22, 2016.
Authority: This data collection effort
is in response to the Elder Justice Act of
2009, which amended title XX of the
Social Security Act (42.U.S.C. 13976 et
seq.). These provisions require that the
Secretary of HHS ‘‘collects and
disseminates data annually relating to
the abuse, exploitation, and neglect of
elders in coordination with the
Department of Justice’’ (Sec.
2041(a)(1)(B)), and ‘‘conducts research
related to the provision of adult
protective services’’ (Sec. 2041(a)(1)(D)).
Furthermore, the Elder Justice
Coordinating Council (EJCC) included
as its third recommendation for
increasing federal involvement in
addressing elder abuse, neglect, and
exploitation: Develop a national adult
protective services (APS) system based
upon standardized data collection and a
core set of service provision standards
and best practices.
Background: From 2013–2015, ACL,
in partnership with the U.S. Department
of Health & Human Services’ Office of
the Assistant Secretary for Planning and
Evaluation (ASPE), developed and pilot
tested NAMRS. When implemented,
NAMRS will be the first comprehensive,
national reporting system for APS
programs. NAMRS is intended to collect
quantitative and qualitative data on the
practices and policies of adult
protective services (APS) agencies, as
well as the outcomes of investigations
into the maltreatment of older adults
and adults with disabilities. In
developing NAMRS, ACL and ASPE
convened key stakeholders to identify
data elements that are the most critical
for a national system. More than 40 state
administrators, researchers, service
providers, and other stakeholders
provided input in focus group
conference calls. Additionally, more
than 30 state representatives from 25
different states met in three in-person
working sessions to discuss the uses of
collected data and the key
functionalities. A pilot version of
NAMRS was tested in nine (9) diverse
states, and refined based on feedback
from the pilot and additional
stakeholder engagement. A full
discussion on the background of
NAMRS, including the development of
the system, the public engagement
process, and the pilot testing can be
found in the NAMRS section of the ACL
Web site.
Number of
respondents
Instrument
Proposed Collection Effort: NAMRS
has been developed as a voluntary
system to collect annually both
summary and de-identified case-level
data on APS investigations. NAMRS
consists of three components:
(1) ACL proposes to collect descriptive
data on state agency policies and practices
from all states through the ‘‘Agency
Component,’’ and
(2) Case-level, non-identifiable data on
persons who receive an investigation by APS
in response to an allegation of abuse, neglect,
or exploitation through the ‘‘Case
Component.’’
(3) For states that are unable to submit a
case-level file through the ‘‘Case
Component,’’ a ‘‘Key Indicators Component’’
will be available for them to submit data on
a smaller set of core items.
ACL will provide technical assistance
to states to assist in the preparation of
their data submissions. Respondents
will be state APS agencies and APS
agencies in the District of Columbia,
Puerto Rico, Guam, Northern Marianas
Islands, Virgin Islands, and American
Samoa. No personally identifiable
information will be collected. ACL has
calculated the following burden
estimates (information on how the
estimates were calculated is available in
the NAMRS section of the ACL Web
site):
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
56
31
25
1
1
1
13
40
150
728
1,240
3,750
Estimated Total Annual Burden Hours .....................................................
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Agency Component .........................................................................................
Key Indicators Component ..............................................................................
Case Component .............................................................................................
........................
........................
........................
5,718
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication of this announcement.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following address: Office
of Management and Budget, Paperwork
Reduction Project, email: OIRA_
Submission@OMB.EOP.GOV; Attention:
Desk Officer for the Administration for
Community Living.
With respect to the collection of
information via NAMRS, ACL
specifically requests comments on:
(a) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the agency,
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including whether the information shall have
practical utility;
(b) the accuracy of the agency’s estimate of
the burden of the proposed collection of
information;
(c) 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.
Consideration will be given to
comments and suggestions submitted
within 30 days of this publication. The
proposed collection of information tools
may be found in the NAMRS section of
the ACL Web site.
Dated: August 2, 2016.
Edwin L. Walker,
Acting Assistant Secretary for Aging.
[FR Doc. 2016–18731 Filed 8–5–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0566]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Alumni
Commissioner’s Fellowship Program
Fellows
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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52440
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
7, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
title Outcomes Evaluation Survey for
Graduates of the FDA Commissioner’s
Fellowship Program. Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Survey of Alumni Commissioner’s
Fellowship Program Fellows—OMB
Control Number 0910–NEW
FDA is requesting approval from the
Office of Management and Budget to
gather information from Alumni
Commissioner’s Fellowship Program
(CFP) Fellows. The information from
Alumni CFP Fellows will allow FDA’s
Office of the Commissioner (OC) to
easily and efficiently elicit and review
program feedback. The online survey
will assist the Agency in promoting and
protecting the public health by
encouraging outside persons to share
their experience with the FDA while a
Commissioner’s Fellow. The process
will reduce the time and cost of
submitting written documentation to the
Agency and lessen the likelihood of
surveys being misrouted within the
Agency mail system. The information
gathered by the survey will be used to
gain insights into, and to document,
impacts that the CFP has had and is
having on former CFP fellows and
contributions and impacts that the
former fellows are making in their
current work. The surveys include
questions to assess the following
measures: Post-fellowship employment
(e.g., employment type); number of
awards; number of contributions while
a CFP fellow (e.g., number of
publications, guidances authored or coauthored); and contributions in their
field (e.g., list of publications).
In the Federal Register of February
24, 2016 (81 FR 9202), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Fellowship Program Survey .....................................
1 There
Number of
responses per
respondent
35
Total annual
responses
1
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18711 Filed 8–5–16; 8:45 am]
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2062]
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Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
SUMMARY:
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In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
SUPPLEMENTARY INFORMATION:
Determination That BENTYL
(Dicyclomine Hydrochloride) Syrup
and Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
ACTION:
0.50 (30 minutes) ......
Total hours
17.5
are no capital costs or operating maintenance costs associated with this collection of information.
FDA based these estimates on the
number of fellows that have graduated
and left the Agency over the past 5
years.
AGENCY:
35
Average burden per
response
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ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness, or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
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]]>Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52439-52440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0566]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Alumni
Commissioner's Fellowship Program Fellows
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget
[[Page 52440]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Fax written comments on the collection of information by
September 7, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the title Outcomes Evaluation Survey
for Graduates of the FDA Commissioner's Fellowship Program. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey of Alumni Commissioner's Fellowship Program Fellows--OMB Control
Number 0910-NEW
FDA is requesting approval from the Office of Management and Budget
to gather information from Alumni Commissioner's Fellowship Program
(CFP) Fellows. The information from Alumni CFP Fellows will allow FDA's
Office of the Commissioner (OC) to easily and efficiently elicit and
review program feedback. The online survey will assist the Agency in
promoting and protecting the public health by encouraging outside
persons to share their experience with the FDA while a Commissioner's
Fellow. The process will reduce the time and cost of submitting written
documentation to the Agency and lessen the likelihood of surveys being
misrouted within the Agency mail system. The information gathered by
the survey will be used to gain insights into, and to document, impacts
that the CFP has had and is having on former CFP fellows and
contributions and impacts that the former fellows are making in their
current work. The surveys include questions to assess the following
measures: Post-fellowship employment (e.g., employment type); number of
awards; number of contributions while a CFP fellow (e.g., number of
publications, guidances authored or co-authored); and contributions in
their field (e.g., list of publications).
In the Federal Register of February 24, 2016 (81 FR 9202), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fellowship Program Survey................... 35 1 35 0.50 (30 minutes)......................... 17.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.
FDA based these estimates on the number of fellows that have
graduated and left the Agency over the past 5 years.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18711 Filed 8-5-16; 8:45 am]
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