Proposed Collection; 60-Day Comment Request; Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases), 15423-15424 [2023-05085]
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Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices
SUPPLEMENTARY INFORMATION:
bioavailability of the drug, potentially
resulting in a loss of efficacy for weakbase drugs or increased toxicity for
weak-acid drugs. Therefore, it is
important to assess the susceptibility of
an investigational drug to gastric pH
change-mediated DDIs early in drug
development, characterize the DDI effect
with clinical studies when needed, and
communicate the relevant findings in
the drug product labeling. This
guidance addresses when clinical DDI
studies with ARAs should be
conducted, the design and conduct of
clinical pH-dependent DDI studies,
alternative approaches for evaluating
pH-dependent DDIs, and extrapolating
clinical DDI study results among drug
classes of ARAs.
This guidance finalizes the draft
guidance entitled ‘‘Evaluation of Gastric
pH-Dependent Drug Interactions With
Acid-Reducing Agents: Study Design,
Data Analysis, and Clinical
Implications’’ issued on December 1,
2020 (85 FR 77222). FDA considered
comments received on the draft
guidance as the guidance was finalized.
Changes from the draft to the final
guidance include: (1) adding footnotes
to update the framework to evaluate the
pH-DDI liability of an investigational
drug based on solubility and dissolution
of a drug product, (2) additional
literature and FDA guidance references
included to provide additional clarity,
(3) modified examples of PPIs and their
doses for clinical DDI studies, and (4)
editorial changes to improve clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Evaluation of
Gastric pH-Dependent Drug Interactions
With Acid-Reducing Agents: Study
Design, Data Analysis, and Clinical
Implications.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Evaluation of Gastric pH-Dependent
Drug Interactions With Acid-Reducing
Agents: Study Design, Data Analysis,
and Clinical Implications.’’ ARAs such
as antacids, histamine H2-receptor
antagonists, and proton pump inhibitors
(PPIs) are widely used, and many of
these drugs are available over-thecounter. Because ARAs can elevate the
gastric pH, concomitant administration
of a drug with an ARA could alter the
solubility, dissolution, and
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information for submissions of
investigational new drug applications,
new drug applications, and biologic
ddrumheller on DSK120RN23PROD with NOTICES1
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
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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Anuradha Ramamoorthy, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3118,
Silver Spring, MD 20993, 240–402–
6426, Anuradha.Ramamoorthy@
fda.hhs.gov.
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license applications in 21 CFR parts
312, 314, and 601 have been approved
under OMB control numbers 0910–
0014, 0910–0001, and 0910–0338,
respectively. The collections of
information in 21 CFR 201.56 and
201.57 pertaining to the submission of
prescription drug labeling have been
approved under OMB control number
0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05067 Filed 3–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Office of Minority Health
Research Coordination (OMHRC)
Research Training and Mentor
Programs Applications (National
Institute of Diabetes and Digestive and
Kidney Diseases)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health National
Institute of Diabetes and Digestive and
Kidney Diseases will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Winnie Martinez, Project
Officer, 6707 Democracy Blvd., 9th
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\13MRN1.SGM
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Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices
Floor, Bethesda, MD 20892 or call nontoll-free number (301) 435–2988 or
Email your request, including your
address to: Winnie.Martinez@nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
school through post-doctoral
educational level individuals into
OMHRC research training and mentor
programs: The Short-Term Research
Experience Program to Unlock Potential
(STEP–UP), the Diversity Summer
Research Training Program (DSRTP) for
Undergraduate Students, and Network
of Minority Health Research
Investigators (NMRI), the NIH/National
Medical Association (NMA) Academic
Career Fellow Travel Awards, and the
NIDDK/National Hispanic Medical
Association (NHMA) Academic Career
Fellow Travel Awards.
Identification of participants to
matriculate into the program and
initiatives comes from applications and
related forms hosted through the NIDDK
website. The proposed information
collection activity is necessary in order
to determine the eligibility and quality
of potential awardees for traineeship in
these programs.
OMB approval is requested for three
(3) years. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 1,651.
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Office of
Minority Health Research Coordination
Training and Mentor Programs
Applications 0925–0748, REVISION,
exp., date 8/31/2023 National Institute
of Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of
Health (NIH).
Need and Use of Information
Collection: In 2000, the National
Institute of Diabetes and Digestive and
Kidney Diseases of the National
Institutes of Health established the
Office of Minority Health Research
Coordination to address the burden of
diseases and disorders that
disproportionately impact the health of
minority populations. One of the major
goals of the office is to build and sustain
a pipeline of researchers from
underrepresented populations in the
biomedical, behavioral, clinical, and
social sciences, with a focus on NIDDK
mission areas. The office accomplishes
this goal by administering a variety of
programs and initiatives to recruit high
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Attachment 1: Short-Term Research Experience Program to Unlock Potential (STEP–UP) Application ..........................................................................
Attachment 2: STEP–UP Student Feedback Form .........................................
Attachment 3: STEP–UP Participant Survey Form .........................................
Attachment 4: Diversity Summer Research Training Program (DSRTP)
Feedback Form ............................................................................................
Attachment 5: Network of Minority Health Research Investigators (NMRI)
Enrollment Form ...........................................................................................
Attachment 6: NMRI Evaluation Form .............................................................
Attachment 7: NMRI Survey Form ..................................................................
Attachment 8: NMRI Mentor-Mentee Agreement Form ..................................
Attachment 9: NIH/National Medical Association (NMA) Academic Career
Fellow Travel Awards Application ................................................................
Attachment 10: NIH/NMA Feedback Form ......................................................
Attachment 11: NIH/NMA Academic Career Development Workshop Contact Information and Feedback Form ...........................................................
Attachment 12: NIH/National Hispanic Medical Association (NHMA) Academic Career Fellow Travel Awards Application .........................................
Attachment 13: NIH/NHMA Feedback Form ...................................................
ddrumheller on DSK120RN23PROD with NOTICES1
Total ..........................................................................................................
Dated: March 7, 2023.
Melbourne L. Bull Jr.,
NIDDK Project Clearance Liaison, Office of
Management Policy Analysis, National
Institute of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health.
[FR Doc. 2023–05085 Filed 3–10–23; 8:45 am]
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5689
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1651
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
PO 00000
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Total annual
burden hours
600
175
2,200
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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per response
(in hours)
Number of
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respondent
Sfmt 4703
amended, notice is hereby given of the
following meeting of the National
Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15423-15424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05085]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Office of Minority
Health Research Coordination (OMHRC) Research Training and Mentor
Programs Applications (National Institute of Diabetes and Digestive and
Kidney Diseases)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health National
Institute of Diabetes and Digestive and Kidney Diseases will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Ms. Winnie
Martinez, Project Officer, 6707 Democracy Blvd., 9th
[[Page 15424]]
Floor, Bethesda, MD 20892 or call non-toll-free number (301) 435-2988
or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Office of Minority Health Research
Coordination Training and Mentor Programs Applications 0925-0748,
REVISION, exp., date 8/31/2023 National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), National Institutes of Health
(NIH).
Need and Use of Information Collection: In 2000, the National
Institute of Diabetes and Digestive and Kidney Diseases of the National
Institutes of Health established the Office of Minority Health Research
Coordination to address the burden of diseases and disorders that
disproportionately impact the health of minority populations. One of
the major goals of the office is to build and sustain a pipeline of
researchers from underrepresented populations in the biomedical,
behavioral, clinical, and social sciences, with a focus on NIDDK
mission areas. The office accomplishes this goal by administering a
variety of programs and initiatives to recruit high school through
post-doctoral educational level individuals into OMHRC research
training and mentor programs: The Short-Term Research Experience
Program to Unlock Potential (STEP-UP), the Diversity Summer Research
Training Program (DSRTP) for Undergraduate Students, and Network of
Minority Health Research Investigators (NMRI), the NIH/National Medical
Association (NMA) Academic Career Fellow Travel Awards, and the NIDDK/
National Hispanic Medical Association (NHMA) Academic Career Fellow
Travel Awards.
Identification of participants to matriculate into the program and
initiatives comes from applications and related forms hosted through
the NIDDK website. The proposed information collection activity is
necessary in order to determine the eligibility and quality of
potential awardees for traineeship in these programs.
OMB approval is requested for three (3) years. There are no costs
to respondents other than their time. The total estimated annualized
burden hours are 1,651.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Attachment 1: Short-Term Research Experience 600 1 1 600
Program to Unlock Potential (STEP-UP)
Application....................................
Attachment 2: STEP-UP Student Feedback Form..... 175 1 15/60 44
Attachment 3: STEP-UP Participant Survey Form... 2,200 1 5/60 183
Attachment 4: Diversity Summer Research Training 14 1 30/60 7
Program (DSRTP) Feedback Form..................
Attachment 5: Network of Minority Health 200 1 15/60 50
Research Investigators (NMRI) Enrollment Form..
Attachment 6: NMRI Evaluation Form.............. 120 1 30/60 60
Attachment 7: NMRI Survey Form.................. 800 1 30/60 400
Attachment 8: NMRI Mentor-Mentee Agreement Form. 100 1 30/60 50
Attachment 9: NIH/National Medical Association 200 1 20/60 67
(NMA) Academic Career Fellow Travel Awards
Application....................................
Attachment 10: NIH/NMA Feedback Form............ 40 1 30/60 20
Attachment 11: NIH/NMA Academic Career 1,000 1 5/60 83
Development Workshop Contact Information and
Feedback Form..................................
Attachment 12: NIH/National Hispanic Medical 200 1 20/60 67
Association (NHMA) Academic Career Fellow
Travel Awards Application......................
Attachment 13: NIH/NHMA Feedback Form........... 40 1 30/60 20
---------------------------------------------------------------
Total....................................... .............. 5689 .............. 1651
----------------------------------------------------------------------------------------------------------------
Dated: March 7, 2023.
Melbourne L. Bull Jr.,
NIDDK Project Clearance Liaison, Office of Management Policy Analysis,
National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health.
[FR Doc. 2023-05085 Filed 3-10-23; 8:45 am]
BILLING CODE 4140-01-P
