Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality, 71650-71651 [2021-27298]
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
products with a USP monograph are
required to meet the applicable criteria
from these USP General Chapters (see
section 501(b) of the FD&C Act).
Noncompendial products should also be
‘‘essentially free from visible
particulates’’ as defined in USP General
Chapter <790>.
Applying acceptance criteria, such as
the criterion outlined in USP General
Chapter <790>, is an important
component of the overall visible
particulate control program, but meeting
these acceptance criteria alone is not
sufficient to ensure compliance with the
applicable CGMP requirements
identified above, which cover a broader
array of manufacturing practices than
product inspection. Full compliance
with CGMP requirements is needed to
ensure the continued supply of pure,
safe, and effective injectable products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Inspection of Injectable Products for
Visible Particulates.’’ 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
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 in 21 CFR parts 211, 314,
and 601 have been approved under
OMB control numbers 0910–0139,
0910–0001, and 0910–0308,
respectively.
jspears on DSK121TN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
VerDate Sep<11>2014
17:39 Dec 16, 2021
Jkt 256001
Dated: December 14, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27351 Filed 12–16–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4164–01–P
National Human Genome Research
Institute; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
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
property such as patentable material,
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 of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Brain Initiative
RFAs (EB–19–002; EB–20–001) Review SEP.
Date: February 11, 2022.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Blvd.,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Songtao Liu, MD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Suite 920, Bethesda, MD
20892, (301) 827–3025, songtao.liu@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, National Institute of
Biomedical Imaging and Bioengineering,
National Institutes of Health, HHS)
Dated: December 10, 2021.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: Center for Inherited
Disease Research Access Committee CIDR
Member Conflict Meeting.
Date: January 14, 2022.
Time: 12:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 3100, Room 3184,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rudy Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, Bldg. 6700B Rockledge Dr., Rm.
3184, 6700B Rockledge Dr., Bethesda, MD
20817, (301) 402–0838, pozzattr@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: December 13, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–27341 Filed 12–16–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NIH Electronic Application
System for NIH Certificates of
Confidentiality
AGENCY:
[FR Doc. 2021–27340 Filed 12–16–21; 8:45 am]
HHS.
BILLING CODE 4140–01–P
ACTION:
PO 00000
National Institutes of Health,
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
SUMMARY:
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71651
Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
opportunity for public comment on
proposed data collection projects, the
Office of Extramural Research (OER), in
the Office of the Director, the National
Institutes of Health (NIH) will publish
periodic summaries of propose 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: Dr. Pamela Reed Kearney,
Division of Human Subjects Research,
OER, NIH, 6705 Rockledge Dr., Building
Rockledge 1, Room 812–C, Bethesda,
MD 20817, or call non-toll-free number
(301) 402–2512 or Email your request,
including your address to: NIH-CoCCoordinator@mail.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
issued by the agencies of the U.S.
Department of Health and Human
Services (HHS), including NIH, to
authorize researchers to protect the
privacy of human research subjects by
prohibiting them from releasing names
and identifying characteristics of
research participants to anyone not
connected with the research, except in
limited circumstances specified in the
statute. At NIH, the issuance of CoCs
has been delegated to the NIH Office of
Extramural Research (OER) in the NIH
Office of the Director. NIH received 795
requests for CoCs from January 2020
through December 2020 and expects to
receive approximately the same number
of requests in subsequent years. NIH has
been using an online CoC system to
review requests and issue CoCs since
2015. The current CoC request form
includes six sections of information
collected from research organizations.
The information provided is used to
determine eligibility for a CoC and to
issue the CoC to the requesting
organization. Eligible requesting
organizations that provide legally
binding affirmations that they will abide
by the terms of the CoC are issued a
Certificate of Confidentiality. This
system has increased efficiency and
reduced burden for both requesters and
NIH staff who currently process these
requests.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1193.
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: Electronic
Application for NIH Certificates of
Confidentiality (CoC E-application
System), 0925–0689, REVISION, exp.,
date 02/28/2023. Office of Extramural
Research (OER), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The current CoC system
sends system communications and the
approved Certificate to the Principal
Investigator and the Institutional
Official. NIH is adding two optional
data fields to the electronic system for
the submission and processing of
requests for NIH to issue Certificates of
Confidentiality (CoCs). The optional
data fields will allow the requester to
identify another person that receives
CoC system communications and the
approved Certificate. This request
system provides one electronic form to
be used by all research organizations
that request a Certificate of
Confidentiality (CoC) from NIH. As
described in the authorizing legislation
(Section 301(d) of the Public Health
Service Act, 42 U.S.C. 241(d)), CoCs are
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Average time
per response
(in hours)
Total annual
burden hour
Life Scientists ...................................................................................................
795
1
90/60
1193
Total ..........................................................................................................
........................
795
........................
1193
Dated: December 11, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–27298 Filed 12–16–21; 8:45 am]
BILLING CODE 4140–01–P
jspears on DSK121TN23PROD with NOTICES1
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
VerDate Sep<11>2014
17:39 Dec 16, 2021
Jkt 256001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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
property such as patentable material,
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 of
Biomedical Imaging and Bioengineering
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71650-71651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH Electronic
Application System for NIH Certificates of Confidentiality
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide
[[Page 71651]]
opportunity for public comment on proposed data collection projects,
the Office of Extramural Research (OER), in the Office of the Director,
the National Institutes of Health (NIH) will publish periodic summaries
of propose 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: Dr. Pamela
Reed Kearney, Division of Human Subjects Research, OER, NIH, 6705
Rockledge Dr., Building Rockledge 1, Room 812-C, Bethesda, MD 20817, or
call non-toll-free number (301) 402-2512 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: Electronic Application for NIH
Certificates of Confidentiality (CoC E-application System), 0925-0689,
REVISION, exp., date 02/28/2023. Office of Extramural Research (OER),
National Institutes of Health (NIH).
Need and Use of Information Collection: The current CoC system
sends system communications and the approved Certificate to the
Principal Investigator and the Institutional Official. NIH is adding
two optional data fields to the electronic system for the submission
and processing of requests for NIH to issue Certificates of
Confidentiality (CoCs). The optional data fields will allow the
requester to identify another person that receives CoC system
communications and the approved Certificate. This request system
provides one electronic form to be used by all research organizations
that request a Certificate of Confidentiality (CoC) from NIH. As
described in the authorizing legislation (Section 301(d) of the Public
Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies
of the U.S. Department of Health and Human Services (HHS), including
NIH, to authorize researchers to protect the privacy of human research
subjects by prohibiting them from releasing names and identifying
characteristics of research participants to anyone not connected with
the research, except in limited circumstances specified in the statute.
At NIH, the issuance of CoCs has been delegated to the NIH Office of
Extramural Research (OER) in the NIH Office of the Director. NIH
received 795 requests for CoCs from January 2020 through December 2020
and expects to receive approximately the same number of requests in
subsequent years. NIH has been using an online CoC system to review
requests and issue CoCs since 2015. The current CoC request form
includes six sections of information collected from research
organizations. The information provided is used to determine
eligibility for a CoC and to issue the CoC to the requesting
organization. Eligible requesting organizations that provide legally
binding affirmations that they will abide by the terms of the CoC are
issued a Certificate of Confidentiality. This system has increased
efficiency and reduced burden for both requesters and NIH staff who
currently process these requests.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1193.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Life Scientists................................. 795 1 90/60 1193
---------------------------------------------------------------
Total....................................... .............. 795 .............. 1193
----------------------------------------------------------------------------------------------------------------
Dated: December 11, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-27298 Filed 12-16-21; 8:45 am]
BILLING CODE 4140-01-P
