Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs, 53739-53740 [2019-21839]
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Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Notices
systems that include timely access to
comprehensive appropriate services and
supports.’’ The Traumatic Brain Injury
Act of 2008 (Pub. L. 110–206) provided
for the expansion and improvement of
traumatic brain injury programs,
including funding for HRSA’s State
Grants for Demonstration Projects
Regarding Traumatic Brain Injury.
These state grants were reauthorized by
the Traumatic Brain Injury
Reauthorization Act of 2014 (Pub. L.
113–196) and again by the Traumatic
Brain Injury Reauthorization Act of
2018 (Pub. L. 115–377).
While conducting a review of all
previous statewide TBI needs and
resources assessments, the HRSA
determined that four common barriers
to accessing care continued to emerge
across states and territories. These
barriers include: (1) A lack of
information of services and supports
with little or no assistance in accessing
them (information and referral services);
(2) a shortage of health professionals
who may encounter individuals with
TBI but lack relevant training to identify
or treat the resulting symptoms,
including physicians, nurses, school
staff, coaches, athletic trainers, social
workers, psychologists, childcare
providers, domestic violence/homeless/
emergency shelter staff, law
enforcement, and assisted living facility
personnel (professional training); (3) the
absence of a TBI diagnosis, or the
assignment of an incorrect diagnosis
(screening); and (4) critical TBI services
are spread across numerous agencies
resulting in services being difficult for
families to identify and navigate
(resource facilitation).
The proposed performance measures
assess progress toward surmounting the
aforementioned barriers, while
accounting for the varied approaches
used across state grantees and are
consistent with the TBI State
Partnership Program’s purpose and
ACL’s mission.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Comments in Response to the 60-Day
Federal Register Notice
Federal Register November 13, 2017
vol. 82, Number 217; pp. 52305–52306.
For the complete extensive summary of
comments and responses, please visit
the ACL website for review. https://
www.acl.gov/about-acl/public-input.
(1) Twenty-three (23) individuals
provided written comments in response
to the proposed new TBI Performance
Measures instrument.
(2) Commenters provided feedback on
specific reporting instrument questions
as well as general suggestions and
recommendations for ACL about what
grantees should report.
(3) 268 separate comments were made
about one or more specific survey
questions.
(4) 102 separate comments asked for
a definition, further guidance or
clarification with regard to terminology
used.
(5) 81 comments made a general
recommendation, not specific to a
particular question.
Estimated Program Burden
These revisions based on public
comments caused a change in the
annual reporting burden estimates; there
is a program change decrease of ¥1,008
annual burden hours from the 60-day
FRN. In addition, the 60-day FRN
respondent estimate was based on the
highest number of possible awards
anticipated; there is an adjustment
decrease of ¥18 respondents.
Adjusted number of
respondents
Number of responses
(per respondent)
Average
burden hours
(per response)
Total burden hours
27 .................................................................................................
2
8
432
60-day FRN number of
respondents
Number of responses
(per respondent)
Average
burden hours
(per response)
Total burden hours
45 .................................................................................................
2
16
1,440
Dated: September 23, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–21906 Filed 10–7–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3728]
BILLING CODE 4154–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Collection of
Conflict of Interest Information for
Participation in Food and Drug
Administration Non-Employee
Fellowship and Traineeship Programs
AGENCY:
jbell on DSK3GLQ082PROD with NOTICES
Summary of Comment Count
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
SUMMARY:
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21:50 Oct 07, 2019
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Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by November
7, 2019.
DATES:
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
OMB control number 0910–NEW and
title ‘‘Collection of Conflict of Interest
Information for Participation in Food
and Drug Administration Non-Employee
Fellowship and Traineeship Programs.’’
Also include the FDA docket number
ADDRESSES:
E:\FR\FM\08OCN1.SGM
08OCN1
53740
Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Notices
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Collection of Conflict of Interest
Information for Participation in Food
and Drug Administration NonEmployee Fellowship and Traineeship
Programs
OMB Control Number 0910–NEW
In compliance with 44 U.S.C. 3507,
FDA will submit to the Office of
Management and Budget a request to
review and approve a new collection of
information: ‘‘Collection of Conflict of
Interest Information for Participation in
FDA Non-Employee Fellowship and
Traineeship Programs.’’ Section 742 (b)
of the Food, Drug and Cosmetic Act (21
U.S.C. 379l) allows FDA to conduct and
support intramural training programs
through fellowship and traineeship
programs. These new forms provide the
FDA with information about financial
investments and relationships from nonemployee scientists who participate in
FDA fellowship and traineeship
programs. Participants in FDA
fellowship and traineeship programs
will be asked for certain information
about financial interests and current
relationships: (1) Description of the
financial interest; (2) the type of
financial interest (e.g. stocks, bonds,
stock options); (3) if the financial
interest is an employee benefit from
prior employment; (4) value of financial
interest; (5) who owns the financial
interest (e.g. self, spouse, minor
children); (6) employment relationship
with an FDA significantly regulated
organization (SRO); (7) and service as a
consultant to an FDA SRO, and/or
proprietary interest(s) in one of more
product(s) regulated by FDA, including
patent, trademark, copyright, or
licensing agreement. The purpose of the
financial information is for FDA to
determine if there is a conflict of
interest between the Fellow’s or
Trainee’s financial and relationship
interests and their activities at FDA. The
collection of information is mandatory
to participate in FDA’s fellowship and
traineeship programs.
In the Federal Register of October 22,
2018 (83 FR 53257), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although two comments
were received, they were not responsive
to the four collection of information
topics solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Activity
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Collection Form—Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
Oak Ridge Institute for Science and Education Fellowship
Traineeship Program ...........................................................
Reagan-Udall Fellowship at FDA ........................................
500
500
50
1
1
1
500
500
50
1
1
1
500
500
50
Total ..............................................................................
........................
........................
........................
........................
1050
1 There
are no capital costs or operating and maintenance costs associated with this collection of information
Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21839 Filed 10–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Changes to the Scholarships
for Disadvantaged Students Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
jbell on DSK3GLQ082PROD with NOTICES
AGENCY:
On May 22, 2019, HRSA
published a 30-day notice in the Federal
Register soliciting feedback on a range
of issues pertaining to the Scholarships
for Disadvantaged Students (SDS)
Program to assist the agency in updating
certain SDS policies. HRSA requested
SUMMARY:
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feedback on adjusting funding
allocations to respond to projected
workforce shortages, transitioning data
collection from 1 year of data to a 3-year
average to demonstrate eligibility, and
increasing the maximum scholarship
award from $30,000 to $40,000. As a
result of HRSA’s comprehensive review
of existing policies, and taking into
consideration the comments received,
HRSA is issuing this final notice.
ADDRESSES: Further information on SDS
Program is available at https://
bhw.hrsa.gov/loansscholarships/
schoolbasedloans/sds.
FOR FURTHER INFORMATION CONTACT:
Denise Sorrell, SDS Project Officer,
Division of Health Careers and Financial
Support, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room 15N78,
Rockville, Maryland 20857, phone (301)
443–2909, or email SDSProgram@
HRSA.gov.
SDS
Program is authorized by Public Health
Service Act (PHS Act) section 737 and
SUPPLEMENTARY INFORMATION:
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administered by HRSA. On May 22,
2019, through a Federal Register Notice
(Volume 84, Number 99, pp. 23571–
23572), HRSA solicited input on
proposed SDS policy changes. HRSA
received comments on the proposed
funding allocation and 3-year data
requirement in response to the
solicitation for feedback.
Comments on the Proposed Changes to
the SDS Program
HRSA received four comments from
two nursing associations, one physician
assistant association, and one primary
care physician assistant program.
Funding Allocation
Summary of Comments
Commenters provided a variety of
input on funding allocations among
health profession disciplines. One
commenter suggested that funding
allocated to schools of nursing should
be reduced or eliminated. Others
expressed concerns that reductions in
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]]>Agencies
[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53739-53740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3728]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Collection of
Conflict of Interest Information for Participation in Food and Drug
Administration Non-Employee Fellowship and Traineeship Programs
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 (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 7, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Collection of Conflict of Interest Information for
Participation in Food and Drug Administration Non-Employee Fellowship
and Traineeship Programs.'' Also include the FDA docket number
[[Page 53740]]
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
Collection of Conflict of Interest Information for Participation in
Food and Drug Administration Non-Employee Fellowship and Traineeship
Programs
OMB Control Number 0910-NEW
In compliance with 44 U.S.C. 3507, FDA will submit to the Office of
Management and Budget a request to review and approve a new collection
of information: ``Collection of Conflict of Interest Information for
Participation in FDA Non-Employee Fellowship and Traineeship
Programs.'' Section 742 (b) of the Food, Drug and Cosmetic Act (21
U.S.C. 379l) allows FDA to conduct and support intramural training
programs through fellowship and traineeship programs. These new forms
provide the FDA with information about financial investments and
relationships from non-employee scientists who participate in FDA
fellowship and traineeship programs. Participants in FDA fellowship and
traineeship programs will be asked for certain information about
financial interests and current relationships: (1) Description of the
financial interest; (2) the type of financial interest (e.g. stocks,
bonds, stock options); (3) if the financial interest is an employee
benefit from prior employment; (4) value of financial interest; (5) who
owns the financial interest (e.g. self, spouse, minor children); (6)
employment relationship with an FDA significantly regulated
organization (SRO); (7) and service as a consultant to an FDA SRO, and/
or proprietary interest(s) in one of more product(s) regulated by FDA,
including patent, trademark, copyright, or licensing agreement. The
purpose of the financial information is for FDA to determine if there
is a conflict of interest between the Fellow's or Trainee's financial
and relationship interests and their activities at FDA. The collection
of information is mandatory to participate in FDA's fellowship and
traineeship programs.
In the Federal Register of October 22, 2018 (83 FR 53257), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, they
were not responsive to the four collection of information topics
solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Average
Activity No. of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Collection Form--Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
----------------------------------------------------------------------------------------------------------------
Oak Ridge Institute for Science 500 1 500 1 500
and Education Fellowship.......
Traineeship Program............. 500 1 500 1 500
Reagan-Udall Fellowship at FDA.. 50 1 50 1 50
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21839 Filed 10-7-19; 8:45 am]
BILLING CODE 4164-01-P
