Agency Information Collection Request. 30-Day Public Comment Request, 19626-19627 [2021-07620]
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19626
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
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the prescription drug Tramadol from
West Virginia to a wholesale fulfillment
pharmacy located in Alabama through
Kentucky in violation of Federal law.
Tramadol, as contained in the drug
product ULTRAM and generic
formulations, is a prescription painkiller
that may induce psychic and physical
dependence.
Based on this conviction, FDA sent
Mr. Reinhard by certified mail on
October 5, 2020, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Reinhard was convicted, as set forth in
section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Mr. Reinhard an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
file a timely request for a hearing would
constitute an election not to use the
opportunity for a hearing and a waiver
of any contentions concerning this
action. Mr. Reinhard received the
proposal on October 10, 2020. He did
not request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and any contentions
concerning his debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Reinhard
has been convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act.
As a result of the foregoing finding,
Mr. Reinhard is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C
Act). Any person with an approved or
pending drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses in any capacity the services of Mr.
Reinhard during his debarment, will be
subject to civil money penalties (section
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17:22 Apr 13, 2021
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307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Reinhard provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment, he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Mr. Reinhard
during his period of debarment, other
than in connection with an audit under
section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of sections 306 and 307 of
the FD&C Act, a ‘‘drug product’’ is
defined as a drug subject to regulation
under section 505, 512, or 802 of the
FD&C Act (21 U.S.C. 355, 360b, or 382)
or under section 351 of the Public
Health Service Act (42 U.S.C. 262)
(section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
Any application by Mr. Reinhard for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1565 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07638 Filed 4–13–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0263]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
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 May 14, 2021.
SUMMARY:
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Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0263–
30D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, or Email: Sherrette.funn@
hhs.gov, or call 202–795–7714.
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: The Protection
of Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form.
Type of Collection: Extension.
OMB No. 0990–0263 Office of the
Assistant Secretary for Health, Office for
Human Research Protections.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a
three-year extension of the Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form, OMB
No. 0990–0263.
The information collected on the form
is to provide a simplified procedure for
institutions engaged in research
conducted or supported by the
Department of Health and Human
Services (HHS) to satisfy the
requirements of HHS regulations for the
protection of human subjects at 45 CFR
46.103 for assurance identification and
IRB certification and declare exemption
status.
Likely Respondents: Institutions
engaged in research involving human
subjects where the research is supported
by HHS. Institutional use of the form is
also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule), which is codified for
HHS at 45 CFR part 46, subpart A.
SUPPLEMENTARY INFORMATION:
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19627
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
ANNUALIZED BURDEN HOUR TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Hours per
response
Response
burden hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
14,000
2
0.5
14,000
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
In compliance with the
requirement of the Paperwork
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 June 14, 2021.
the document identifier 0990–0260–
60D, and project title for reference, to
Sherrette Funn, email: Sherrette.Funn@
hhs.gov, or call 202–795–7714 the
Reports Clearance Officer.
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: Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: Extension.
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
OMB No. 0990–0260 Office of the
Assistant Secretary for Health, Office
for Human Research Protections
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a
[FR Doc. 2021–07620 Filed 4–13–21; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0260]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY:
ADDRESSES:
three-year extension of the Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation, OMB
No. 0990–0260.
Information reported to the Federal
departments and agencies under the
Common Rule with respect to a
satisfactory assurance is used to ensure
that an institution engaged in nonexempt research involving human
subjects conducted or supported by a
Common Rule department or agency has
(1) established adequate administrative
policies and procedures for protecting
the rights and welfare of human subjects
in research, and (2) accepts that
responsibility. Other reporting
requirements are used to: Assess
whether the institution is following the
established procedures; ensure that
Federal funds are not expended for
unapproved human subjects research;
and, determine if the approved status of
an awarded grant, contract, or
cooperative agreement should be
reviewed, with the ultimate goal of
maintaining or increasing human
subject protections.
Likely Respondents: Institutions,
institutional review boards and
investigators.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Common rule provision
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113
[2018 Requirements]—Incident Reporting, Suspension
or Termination of IRB approval Reporting .......................
5,200
1
5,200
1
5,200
Total ..............................................................................
........................
........................
5,200
........................
5,200
TABLE 2—ESTIMATED ANNUAL IRB RECORDKEEPING BURDEN
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Common rule provision
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
.115 [Pre-2018 and 2018 Requirement]—Preparation and
documentation of IRB activities ........................................
6,000
16
96,000
12
1,152,000
Total ..............................................................................
........................
........................
96,000
........................
1,152,000
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]]>Agencies
[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19626-19627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0263]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork 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 May 14, 2021.
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 0990-0263-30D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, or Email: [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: The Protection of Human Subjects:
Assurance Identification/IRB Certification/Declaration of Exemption
Form.
Type of Collection: Extension.
OMB No. 0990-0263 Office of the Assistant Secretary for Health,
Office for Human Research Protections.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting a three-year extension of
the Protection of Human Subjects: Assurance Identification/IRB
Certification/Declaration of Exemption Form, OMB No. 0990-0263.
The information collected on the form is to provide a simplified
procedure for institutions engaged in research conducted or supported
by the Department of Health and Human Services (HHS) to satisfy the
requirements of HHS regulations for the protection of human subjects at
45 CFR 46.103 for assurance identification and IRB certification and
declare exemption status.
Likely Respondents: Institutions engaged in research involving
human subjects where the research is supported by HHS. Institutional
use of the form is also relied upon by other federal departments and
agencies that have codified or follow the Federal Policy for the
Protection of Human Subjects (Common Rule), which is codified for HHS
at 45 CFR part 46, subpart A.
[[Page 19627]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Response
respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance 14,000 2 0.5 14,000
Identification/IRB Certification/
Declaration of Exemption...................
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-07620 Filed 4-13-21; 8:45 am]
BILLING CODE 4150-36-P
