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, 76628-76629 [2022-27194]
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76628
Federal Register / Vol. 87, No. 240 / Thursday, December 15, 2022 / Notices
information collection request addresses
the burden associated with the
completion of the applicable CMS–855A
by REHs in order to enroll in Medicare.
As part of this request, and as
described in the supporting statement,
we also seek approval for additional
changes to the CMS–855A. These
changes principally (though not
exclusively) involve the collection of
information related to the provider’s
ownership. Form Number: CMS–855A
(OMB control number: 0938–0685);
Frequency: On occasion; Affected
Public: Business or other for-profits, notfor-profit institutions; Number of
Respondents: 1,340; Total Annual
Responses: 5,881; Total Annual Hours:
72,147. (For policy questions regarding
this collection contact Frank Whelan at
410–786–1302.)
Dated: December 9, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–27166 Filed 12–14–22; 8:45 am]
BILLING CODE 4120–01–P
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.
The Food and Drug
Administration (FDA or we) 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: Submit written comments
(including recommendations) on the
collection of information by January 17,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0882. Also include
the FDA docket number 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.
SUMMARY:
Collection of Conflict-of-Interest
Information for Participation in Food
and Drug Administration NonEmployee Fellowship and Traineeship
Programs
OMB Control Number 0910–0882—
Extension
Section 742(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379l(b)) allows FDA to conduct and
support intramural training programs
through fellowship and traineeship
programs. Prospective participants in
these programs must complete financial
disclosure forms to determine if there is
a conflict of interest that would
preclude participation. These new forms
provide 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); and (7)
service as a consultant to an FDA SRO,
and/or proprietary interest(s) in one of
more product(s) regulated by FDA,
including a 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 July 7, 2022
(87 FR 40537), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
Although one comment was received, it
was 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
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
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 ..............................................................................
........................
........................
........................
........................
1,050
1 There
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
16:51 Dec 14, 2022
Jkt 259001
OMB approval, we have made no
adjustments to our burden estimate.
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Federal Register / Vol. 87, No. 240 / Thursday, December 15, 2022 / Notices
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
[FR Doc. 2022–27194 Filed 12–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1319]
Pulmonary Tuberculosis: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Pulmonary Tuberculosis: Developing
Drugs for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the clinical development of new
antibacterial drugs for the treatment of
pulmonary tuberculosis (TB). This draft
guidance does not address the
development of drugs for latent TB
infection or for extrapulmonary TB.
This draft guidance revises and replaces
the draft guidance for industry of the
same name published on November 6,
2013.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by February 13, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
VerDate Sep<11>2014
16:51 Dec 14, 2022
Jkt 259001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–1319 for ‘‘Pulmonary
Tuberculosis: Developing Drugs for
Treatment.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
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76629
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ramya Gopinath, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6154,
Silver Spring, MD 20993–0002, 240–
402–5328.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pulmonary Tuberculosis: Developing
Drugs for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the clinical development of
investigational drugs for the treatment
of pulmonary TB. Specifically, this draft
guidance provides FDA’s current
recommendations regarding the overall
development program and clinical trial
designs for a new investigational drug or
drugs to be used in combination with
approved drugs or a new treatment
regimen that includes one or more
investigational drugs to support an
indication for the treatment of
pulmonary TB.
This draft guidance will revise and
replace the draft guidance for industry
of the same name issued November 6,
2013 (78 FR 66744). Since the 2013 final
guidance was issued, there have been
improvements in nonclinical models
and further interest in streamlined
clinical development programs as well
as consideration for combination
E:\FR\FM\15DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76628-76629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27194]
-----------------------------------------------------------------------
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 or we) 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: Submit written comments (including recommendations) on the
collection of information by January 17, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0882. Also include the FDA docket
number 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 0910-0882--Extension
Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379l(b)) allows FDA to conduct and support intramural training
programs through fellowship and traineeship programs. Prospective
participants in these programs must complete financial disclosure forms
to determine if there is a conflict of interest that would preclude
participation. These new forms provide 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); and (7) service as a
consultant to an FDA SRO, and/or proprietary interest(s) in one of more
product(s) regulated by FDA, including a 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 July 7, 2022 (87 FR 40537), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
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
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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....................... .............. .............. .............. .............. 1,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
[[Page 76629]]
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27194 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P
