Agency Father Generic Information Collection Request; 60-Day Public Comment Request, 31786-31787 [2020-11289]
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Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Notices
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800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Timothy
McGovern, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6426, Silver Spring,
MD 20993–0002, 240–402–0477; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
Regarding the ICH: Amanda Roache,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6364, Silver Spring,
MD 20993–0002, 301–796–4548,
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, regulatory authorities
and industry associations from around
the world have participated in many
important initiatives to promote
international harmonization of
regulatory requirements under the ICH.
FDA has participated in several ICH
meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and reduce
differences in technical requirements for
drug development among regulatory
agencies.
ICH was established to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; FDA; the Japanese
Ministry of Health, Labour, and Welfare;
the Japanese Pharmaceutical
Manufacturers Association; and the
Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. Any party eligible as a
Member in accordance with the ICH
Articles of Association can apply for
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16:59 May 26, 2020
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membership in writing to the ICH
Secretariat. The ICH Secretariat, which
coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the Members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers. The Assembly
is responsible for the endorsement of
draft guidelines and adoption of final
guidelines. FDA publishes ICH
guidelines as FDA guidance.
In the Federal Register of December
24, 1997 (62 FR 67377), FDA published
a notice announcing the availability of
the ICH guidance for industry entitled
‘‘Q3C Impurities: Residual Solvents.’’
The guidance makes recommendations
as to what amounts of residual solvents
are considered toxicologically
acceptable for some residual solvents, or
permitted daily exposure. Upon
issuance in 1997, the text and appendix
1 of the guidance contained several
tables and a list of solvents categorizing
residual solvents by toxicity, classes 1
through 3, with class 1 being the most
toxic. The ICH Quality Expert Working
Group (EWG) agreed that the PDEs
could be modified if reliable and more
relevant toxicity data were brought to
the attention of the group and the
modified PDE could result in a revision
of the tables and list.
In 1999, ICH instituted a Q3C
maintenance agreement and formed a
maintenance EWG (the Q3C EWG). The
agreement provided for the revisitation
of solvent PDEs and allowed for minor
changes to the tables and list that
include the existing PDEs. The
agreement also provided for new
solvents and PDEs that could be added
to the tables and list based on adequate
toxicity data. In the Federal Register of
February 12, 2002 (67 FR 6542), FDA
briefly described the process for
proposing future revisions to the PDEs.
In the same notice, the Agency
announced its decision to remove the
link to the tables and list in the Q3C
guidance and create a stand-alone
document entitled ‘‘Q3C: Tables and
List’’ to facilitate making changes
recommended by ICH; the document is
available at https://www.fda.gov/
downloads/drugs/guidancecompliance
regulatoryinformation/guidances/
ucm073395.pdf. ‘‘Q3C: Tables and List’’
was updated in January 2017 to include
the recommended PDE for triethylamine
and methylisobutylketone.
In March 2020, the ICH Assembly
endorsed the draft PDEs for three
solvents—2-methyltetrahydrofuran,
cyclopentyl methyl ether, and tert-butyl
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alcohol—and agreed that the guidance
should be made available for public
comment. The draft guidance is the
product of the ICH Q3C EWG.
Comments on this draft will be
considered by FDA and the Quality
EWG.
This draft guidance has been left in
the original ICH format. The final
guidance will be reformatted and edited
to conform with FDA’s good guidance
practices regulation (21 CFR 10.115) and
style before publication. The draft
guidance, when finalized, will represent
the current thinking of FDA on the PDEs
for 2-methyltetrahydrofuran,
cyclopentyl methyl ether, and tert-butyl
alcohol. 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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
part 58 pertaining to good laboratory
practice for nonclinical laboratory
studies have been approved under OMB
control number 0910–0119.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11280 Filed 5–26–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0421]
Agency Father Generic Information
Collection Request; 60-Day Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
SUMMARY:
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Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Notices
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 27, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0421–
60D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
evaluation, research and demonstration
activities, and manages crossDepartment planning activities such as
strategic planning, legislative planning,
and review of regulations. Integral to
this role, ASPE will use this mechanism
to conduct qualitative research,
evaluation, or assessment, conduct
analyses, and understand needs,
barriers, or facilitators for HHS-related
programs.
Need and Proposed Use of the
Information: ASPE is requesting
comment on the burden for qualitative
research aimed at understanding
emerging health and human services
policy issues. The goal of developing
these activities is to identify emerging
issues and research gaps to ensure the
successful implementation of HHS
programs. The participants may include
health and human services experts;
national, state, and local health or
human services representatives; public
health, human services, or healthcare
providers; and representatives of other
health or human services organizations.
The increase in burden from 747 in
2014 to 1,300 respondents in 2017
reflects an increase in the number of
research projects conducted over the
estimate in 2014.
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: ASPE Generic
Clearance for the Collection of
Qualitative Research and Assessment.
OMB No.: 0990–0421.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) is requesting an extension for
their generic clearance for purposes of
conducting qualitative research. ASPE
conducts qualitative research to gain a
better understanding of emerging health
policy issues, develop future intramural
and extramural research projects, and to
ensure HHS leadership, agencies and
offices have recent data and information
to inform program and policy decisionmaking. ASPE is requesting approval for
at least four types of qualitative
research: (a) Interviews, (b) focus
groups, (c) questionnaires, and (d) other
qualitative methods.
ASPE’s mission is to advise the
Secretary of the Department of Health
and Human Services on policy
development in health, disability,
human services, data, and science, and
provides advice and analysis on
economic policy. ASPE leads special
initiatives, coordinates the Department’s
ESTIMATED ANNUALIZED BURDEN TABLE
Type of respondent
Form
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Health Policy Stakeholder .................
Qualitative Research ........................
1,300
1
1
1,300
Dated: May 13, 2020.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2020–11289 Filed 5–26–20; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
property such as patentable material,
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and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Step Up
for Substance Use Disorders (SUD): A Drug
Target Initiative for Scientists Engaged in
Fundamental Research (U18—Clinical Trial
Not Allowed).
Date: June 9, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neurosciences Center Building, 6001
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Trinh T. Tran, Scientific
Research Officer, Office of Extramural Policy
and Review, Division of Extramural
Research, National Institute on Drug Abuse,
NIH, 6001 Executive Boulevard, Room 4238,
MSC 9550, Bethesda, MD 20892, (301) 827–
5843, trinh.tran@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
PO 00000
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Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
Dated: May 20, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–11275 Filed 5–26–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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]]>Agencies
[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Notices]
[Pages 31786-31787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0421]
Agency Father Generic Information Collection Request; 60-Day
Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork
[[Page 31787]]
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, is publishing the following summary of a
proposed collection for public comment.
DATES: Comments on the ICR must be received on or before July 27, 2020.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0421-60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], or call 202-795-7714.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: ASPE Generic Clearance for the Collection
of Qualitative Research and Assessment.
OMB No.: 0990-0421.
Abstract: The Office of the Assistant Secretary for Planning and
Evaluation (ASPE) is requesting an extension for their generic
clearance for purposes of conducting qualitative research. ASPE
conducts qualitative research to gain a better understanding of
emerging health policy issues, develop future intramural and extramural
research projects, and to ensure HHS leadership, agencies and offices
have recent data and information to inform program and policy decision-
making. ASPE is requesting approval for at least four types of
qualitative research: (a) Interviews, (b) focus groups, (c)
questionnaires, and (d) other qualitative methods.
ASPE's mission is to advise the Secretary of the Department of
Health and Human Services on policy development in health, disability,
human services, data, and science, and provides advice and analysis on
economic policy. ASPE leads special initiatives, coordinates the
Department's evaluation, research and demonstration activities, and
manages cross-Department planning activities such as strategic
planning, legislative planning, and review of regulations. Integral to
this role, ASPE will use this mechanism to conduct qualitative
research, evaluation, or assessment, conduct analyses, and understand
needs, barriers, or facilitators for HHS-related programs.
Need and Proposed Use of the Information: ASPE is requesting
comment on the burden for qualitative research aimed at understanding
emerging health and human services policy issues. The goal of
developing these activities is to identify emerging issues and research
gaps to ensure the successful implementation of HHS programs. The
participants may include health and human services experts; national,
state, and local health or human services representatives; public
health, human services, or healthcare providers; and representatives of
other health or human services organizations. The increase in burden
from 747 in 2014 to 1,300 respondents in 2017 reflects an increase in
the number of research projects conducted over the estimate in 2014.
Estimated Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form Number of responses per hours per Total burden
respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Health Policy Stakeholder....................... Qualitative Research.............. 1,300 1 1 1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: May 13, 2020.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2020-11289 Filed 5-26-20; 8:45 am]
BILLING CODE 4150-05-P
