Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 16221-16222 [2021-06266]
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Federal Register / Vol. 86, No. 57 / Friday, March 26, 2021 / Notices
nominations for non-voting industry
representatives.
Nominations received on or
before May 25, 2021 will be given first
consideration for membership on the
Blood Products Advisory Committee.
Nominations received after May 25,
2021 will be considered for nomination
to the Committee as later vacancies
occur.
DATES:
All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
factrsportal/factrs/index.cfm.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s website at
https://www.fda.gov/advisorycommittees.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268,
Silver Spring, MD 20993–0002, 240–
402–8054, Fax: 301–595–1309, email:
BPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Blood Products Advisory
Committee.
khammond on DSKJM1Z7X2PROD with NOTICES
I. General Description of the Committee
Duties
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology that are
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which FDA has regulatory
responsibility. The Committee also
advises the Commissioner of Food and
Drugs (the Commissioner) of its findings
regarding screening and testing (to
determine eligibility) of donors and
labeling of the products, on clinical and
laboratory studies involving such
products, on the affirmation or
revocation of biological products
licenses, and on the quality and
relevance of FDA’s research program
that provides the scientific support for
regulating these agents. The Committee
will function at times as a medical
device panel under the Federal Food,
Drug, and Cosmetic Act (FD&C Act)
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Medical Device Amendments of 1976.
As such, the Committee recommends
classification of devices subject to its
review into regulatory categories;
recommends the assignment of a
priority for the application of regulatory
requirements for devices classified in
the standards or premarket approval
category; advises on formulation of
product development protocols and
reviews premarket approval
applications for those devices to
recommend changes in classification as
appropriate; recommends exemption of
certain devices from the application of
portions of the FD&C Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices.
II. Criteria for Voting Members
The Committee consists of a core of
17 voting members, including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
biological and physical sciences,
biotechnology, computer technology,
statistics, epidemiology, sociology/
ethics, and other related professions.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address, telephone number,
and email address if available and a
signed copy of the Acknowledgement
and Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES). Nominations must specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
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16221
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06259 Filed 3–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–1671, FDA–
2014–N–0386, FDA–2011–N–0076, FDA–
2008–N–0312, FDA–2020–N–1677, FDA–
2014–N–1072, and FDA–2019–N–5900]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 86, No. 57 / Friday, March 26, 2021 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB Control
No.
Title of collection
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies .................................................
Orphan Drugs ..........................................................................................................................................................
Electronic Records: Electronic Signatures ..............................................................................................................
Extra Label Drug Use in Animals ............................................................................................................................
Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed
With, or Otherwise Containing, Material from Cattle ...........................................................................................
Application for Participation in Food and Drug Administration Fellowship Programs ............................................
Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion ..................................................
Dated: March 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06266 Filed 3–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2002]
Thomas J. Whalen: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Thomas J. Whalen for a period of 10
years from importing or offering for
import any drug into the United States.
FDA bases this order on a finding that
Mr. Whalen was convicted of multiple
offenses; two of these are relevant to this
debarment: One count of importation
contrary of law-aiding and abetting and
one count of healthcare fraud-aiding
and abetting. The factual basis
supporting Mr. Whalen’s conviction is
conduct relating to the importation into
the United States of a drug or controlled
substance. Mr. Whalen was given notice
of the proposed debarment and was
given an opportunity to request a
hearing to show why he should not be
debarred. As of January 13, 2021 (30
days after receipt of the notice), Mr.
Whalen had not responded. Mr.
Whalen’s failure to respond and request
a hearing constitutes a waiver of his
right to a hearing concerning this
matter.
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SUMMARY:
This order is applicable March
26, 2021.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff (HFA–305), Food and
DATES:
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Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if FDA finds,
as required by section 306(b)(3)(C) of the
FD&C Act, that the individual has been
convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance. On September 15, 2020, Mr.
Whalen was convicted, as defined in
section 306(l)(1) of the FD&C Act, in the
U.S. District Court for the Eastern
District of Pennsylvania, when the court
entered judgment against him for
multiple offenses, two of which are
relevant to this debarment: One count of
importation contrary to law-aiding and
abetting in violation of 18 U.S.C. 545
and 2, and one count of healthcare
fraud-aiding and abetting in violation of
18 U.S.C. 1347 and 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for this conviction is as
follows: As contained in the information
in Mr. Whalen’s case, filed on October
25, 2019, to which he pleaded guilty, he
was a doctor of osteopathy in the
Commonwealth of Pennsylvania and the
State of Delaware. From about January
2014 to about March 2018, Mr. Whalen
engaged in a scheme to defraud
Medicare, the U.S. Office of Personnel
Management (OPM), and the
Independence Blue Cross insurance
company (IBC). Specifically, he
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Date approval
expires
0910–0119
0910–0167
0910–0303
0910–0325
02/29/2024
02/29/2024
02/29/2024
02/29/2024
0910–0623
0910–0780
0910–0894
02/29/2024
02/29/2024
02/29/2024
purchased, imported into the United
States, and distributed misbranded and
non-FDA-approved injectable versions
of REMICADE (infliximab), SYNVISC/
SYNVISC ONE (hyaluronan), ORENCIA
(abatacept), PROLIA/XGEVA
(denosumab), and BONIVA (ibandronate
sodium). He then injected his patients
with these non-FDA-approved versions
of these medications. Mr. Whalen billed
Medicare, OPM, and IBC for the
provision of the FDA-approved versions
of these products.
As a result of this conviction, FDA
sent Mr. Whalen, by United Parcel
Service, on December 11, 2020, a notice
proposing to debar him for a 10-year
period from importing or offering for
import any drug into the United States.
The proposal was based on a finding
under section 306(b)(3)(C) of the FD&C
Act that Mr. Whalen’s felony conviction
for two felony counts under Federal law
related to this debarment, specifically
for one count of importation contrary to
law-aiding and abetting and one count
of healthcare fraud-aiding and abetting,
was for conduct relating to the
importation into the United States of
any drug or controlled substance,
because he illegally imported
unapproved and misbranded drugs into
the United States and then distributed
those misbranded and unapproved
drugs to consumers in the United States.
In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Mr.
Whalen’s offenses and concluded that
each felony offense warranted the
imposition of a 5-year period of
debarment, for a total debarment period
of 10 years. The proposal informed Mr.
Whalen of the proposed debarment and
offered him 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 request a hearing constituted
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. Mr. Whalen received the
proposal and notice of opportunity for
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]]>Agencies
[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16221-16222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-N-1671, FDA-2014-N-0386, FDA-2011-N-0076, FDA-
2008-N-0312, FDA-2020-N-1677, FDA-2014-N-1072, and FDA-2019-N-5900]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
[[Page 16222]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB Control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Good Laboratory Practice (GLP) 0910-0119 02/29/2024
Regulations for Nonclinical Laboratory
Studies................................
Orphan Drugs............................ 0910-0167 02/29/2024
Electronic Records: Electronic 0910-0303 02/29/2024
Signatures.............................
Extra Label Drug Use in Animals......... 0910-0325 02/29/2024
Reporting and Recordkeeping Requirements 0910-0623 02/29/2024
for Human Food and Cosmetics
Manufactured from, Processed With, or
Otherwise Containing, Material from
Cattle.................................
Application for Participation in Food 0910-0780 02/29/2024
and Drug Administration Fellowship
Programs...............................
Endorser Status and Explicitness of 0910-0894 02/29/2024
Payment in Direct-to-Consumer Promotion
------------------------------------------------------------------------
Dated: March 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06266 Filed 3-25-21; 8:45 am]
BILLING CODE 4164-01-P
