Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 54457-54458 [2021-21386]
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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
2009, discussing the DMAA in USP
Labs’ products, Mr. Patel told two of his
co-conspirators, ‘‘lol stuff is completely
100% synthethic [sic].’’ From at least
2008 until at least 2013, USP Labs
frequently imported other potential
dietary compounds from China, under
false labeling, to determine if they could
be used in new dietary supplements.
One of those synthetic compounds was
called ‘‘aegeline.’’ The first aegelinecontaining version of OxyElite Pro,
which was called OxyElite ‘‘New
Formula,’’ went on sale in November
2012. USP Labs reformulated the DMAA
product in the summer of 2013 to
contain aegeline and powder derived
from a Chinese herb called cynanchum
auriculatum. On or about June 15, 2013,
one of Mr. Patel’s co-conspirators at
USP Labs instructed a Chinese company
to have 2 metric tons of ground
cynanchum auriculatum root powder
shipped internationally to S.K.
Laboratories in California for inclusion
in USP Labs’ products, using the false
name ‘‘cynanchum auriculatum root
extract.’’ USP Labs sent false labels
listing ‘‘cynanchum auriculatum (root)
extract’’ as an ingredient in its OxyElite
Pro ‘‘Advanced Formula’’ supplement to
retailers and wholesalers. On or about
October 4, 2013, Mr. Patel and his coconspirators shipped and caused the
shipment of misbranded OxyElite Pro
‘‘Advanced Formula’’ into interstate
commerce. The food was misbranded
because its labeling falsely declared
cynanchum auriculatum (root) extract as
an ingredient even though it was not
contained in the product.
As a result of this conviction FDA
sent Mr. Patel, by certified mail on May
27, 2021, a notice proposing to debar
him for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Patel’s felony
conviction of conspiracy to introduce
misbranded food into interstate
commerce with an intent to defraud and
mislead in violation of 18 U.S.C. 371 (21
U.S.C. 331(a) and 333(a)(2)) constitutes
conduct relating to the importation into
the United States of an article of food
because Mr. Patel was engaged in a
conspiracy with others to import a
variety of potential dietary compounds
from a Chinese company as prospective
and actual ingredients for use in dietary
supplements, and instructed and agreed
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18:04 Sep 30, 2021
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to have those powders labeled falsely as
other food substances. The proposal was
also based on a determination, after
consideration of the relevant factors set
forth in section 306(c)(3) of the FD&C
Act, that Mr. Patel should be subject to
a 5-year period of debarment. The
proposal also offered Mr. Patel an
opportunity to request a hearing,
providing Mr. Patel 30 days from the
date of receipt of the letter in which to
file the request, and advised Mr. Patel
that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. Patel failed
to respond within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and waived 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(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Sitesh
Bansi Patel has been convicted of a
felony count under Federal law for
conduct relating to the importation into
the United States of an article of food
and that he is subject to a 5-year period
of debarment.
As a result of the foregoing finding,
Mr. Patel is debarred for a period of 5
years from importing articles of food or
offering such articles for import into the
United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C
Act (21 U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Mr.
Sitesh Bansi Patel is a prohibited act.
Any application by Mr. Patel for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0269 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
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.
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54457
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21375 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–2231; FDA–
2011–N–0362; FDA–2018–N–0073; FDA–
2018–N–0074; FDA–2010–N–0155; FDA–
2011–N–0781; FDA–2021–N–0525; FDA–
2014–N–0987; FDA–2020–N–1657; FDA–
2017–N–6931; FDA–2020–N–2217; FDA–
2012–N–0369; FDA–2017–N–6730; FDA–
2020–N–1207; FDA–2012–N–0115; FDA–
2021–N–0363; FDA–2009–N–0025; FDA–
2012–N–0547; FDA–2014–N–2347; FDA–
2018–N–1129; FDA–2021–N–0387; FDA–
2020–N–1261; and FDA–2020–N–1644]
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 or Agency) 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:
E:\FR\FM\01OCN1.SGM
01OCN1
54458
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Blood Establishment Registration and Product Listing for Manufacturers of Blood and Blood Products and Licensed Devices ....................................................................................................................................................
Current Good Manufacturing Practice: Manufacturing, Processing, Packing, and Holding of Drugs; GMP for
Finished Pharmaceuticals (Including Gases and Active Pharmaceutical Ingredients) .......................................
Irradiation in the Production, Processing, and Handling of Food ...........................................................................
State Enforcement Notifications ..............................................................................................................................
Veterinary Feed Directive ........................................................................................................................................
Record Retention Requirements for the Soy Protein/Coronary Heart Disease Health Claim ................................
Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements .........................................
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................
Survey of Drug Product Manufacturing, Processing, and Packing Facilities ..........................................................
Current Good Manufacturing Practices for Blood and Related Regulations for Blood Components; and Requirements for Donor Testing, Donor Notification and ‘‘Lookback’’ ....................................................................
New Animal Drugs for Investigational Use ..............................................................................................................
Regulations Under the Federal Import Milk Act ......................................................................................................
Medical Device Reporting ........................................................................................................................................
New Plant Varieties Intended for Food Use ............................................................................................................
Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle .........................................................................................
Prescription Drug Advertisements ...........................................................................................................................
Animal Food Labeling; Declaration of Certifiable Color Additives ..........................................................................
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Food Service Facility
Types ....................................................................................................................................................................
Food and Cosmetic Export Certificates ...................................................................................................................
National Agriculture and Food Defense Strategy Survey .......................................................................................
Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling—Questions and Answers ...............................................................................................................................
Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities
Questions and Answers .......................................................................................................................................
Study of Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an
Approved Prescription Drug .................................................................................................................................
Medical Conference Attendees’ Observations About Prescription Drug Promotion ...............................................
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21386 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Final Policy: Updates to Uniform
Standard for Waiver of the Ryan White
HIV/AIDS Program Core Medical
Services Expenditure Requirement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of final policy.
AGENCY:
The Ryan White HIV/AIDS
Program (RWHAP) statute of the Public
Health Services Act requires that
RWHAP Part A, B, and C recipients
expend not less than 75 percent of Parts
A, B, and C grant funds on core medical
services for individuals with HIV/AIDS
identified and eligible under the statute,
after reserving statutory permissible
SUMMARY:
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amounts for administrative and clinical
quality management (CQM) costs. The
statute also grants the Secretary of HHS
authority to waive this requirement if
certain requirements are met. HRSA has
simplified the process for RWHAP Part
A, B, and C recipients to request a
waiver of the core medical services
expenditure amount requirement by
replacing HRSA Policy Number 13–07,
‘‘Uniform Standard for Waiver of Core
Medical Services Requirement for
Grantees Under Parts, A, B, and C’’ with
Policy Notice 21–01, ‘‘Waiver of the
Ryan White HIV/AIDS Program Core
Medical Services Expenditure
Requirement.’’
DATES: The final policy is effective on
October 1, 2021.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Emeka Egwim,
U.S. Public Health Service, Senior
Policy Analyst, Division of Policy &
Data, HRSA, HIV/AIDS Bureau, 5600
Fishers Lane, Rockville, MD 20857,
Phone: (301) 945–9637 or by emailing
RWHAPPolicy@hrsa.gov. When
requesting information, please include
this Federal Register notice title for
reference.
SUPPLEMENTARY INFORMATION: The
RWHAP statute also grants the Secretary
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Date approval
expires
0910–0052
7/31/2024
0910–0139
0910–0186
0910–0275
0910–0363
0910–0428
0910–0435
0910–0796
0910–0899
7/31/2024
7/31/2024
7/31/2024
7/31/2024
7/31/2024
7/31/2024
7/31/2024
7/31/2024
0910–0116
0910–0117
0910–0212
0910–0437
0910–0583
8/31/2024
8/31/2024
8/31/2024
8/31/2024
8/31/2024
0910–0594
0910–0686
0910–0721
8/31/2024
8/31/2024
8/31/2024
0910–0744
0910–0793
0910–0855
8/31/2024
8/31/2024
8/31/2024
0910–0856
8/31/2024
0910–0857
8/31/2024
0910–0900
0910–0901
8/31/2024
8/31/2024
of HHS authority to waive this
requirement for RWHAP Parts A, B, or
C recipients if a number of requirements
are met and a waiver request is
submitted to HRSA for approval.
RWHAP Part A, B, and C core medical
services waiver requests—if approved—
are effective for a 1-year budget period,
and apply to funds awarded under the
Minority AIDS Initiative.
Currently, for a core medical services
waiver request to be approved, (1) core
medical services must be available and
accessible to all individuals identified
and eligible for the RWHAP in the
recipient’s service area within 30 days,
without regard to payer source; (2) there
cannot be any AIDS Drug Assistance
Program (ADAP) waiting lists in the
recipient’s service area; and (3) a public
process to obtain input on the waiver
request from impacted communities,
including clients and RWHAP-funded
core medical services providers, on the
availability of core medical services and
the decision to request the waiver must
have occurred. The public process may
be a part of the same one used to seek
input on community needs as part of the
annual priority setting and resource
allocation, comprehensive planning,
statewide coordinated statement of
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54457-54458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21386]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-N-2231; FDA-2011-N-0362; FDA-2018-N-0073; FDA-
2018-N-0074; FDA-2010-N-0155; FDA-2011-N-0781; FDA-2021-N-0525; FDA-
2014-N-0987; FDA-2020-N-1657; FDA-2017-N-6931; FDA-2020-N-2217; FDA-
2012-N-0369; FDA-2017-N-6730; FDA-2020-N-1207; FDA-2012-N-0115; FDA-
2021-N-0363; FDA-2009-N-0025; FDA-2012-N-0547; FDA-2014-N-2347; FDA-
2018-N-1129; FDA-2021-N-0387; FDA-2020-N-1261; and FDA-2020-N-1644]
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 or Agency) 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 54458]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Blood Establishment Registration and 0910-0052 7/31/2024
Product Listing for Manufacturers of
Blood and Blood Products and Licensed
Devices................................
Current Good Manufacturing Practice: 0910-0139 7/31/2024
Manufacturing, Processing, Packing, and
Holding of Drugs; GMP for Finished
Pharmaceuticals (Including Gases and
Active Pharmaceutical Ingredients).....
Irradiation in the Production, 0910-0186 7/31/2024
Processing, and Handling of Food.......
State Enforcement Notifications......... 0910-0275 7/31/2024
Veterinary Feed Directive............... 0910-0363 7/31/2024
Record Retention Requirements for the 0910-0428 7/31/2024
Soy Protein/Coronary Heart Disease
Health Claim...........................
Prescription Drug Marketing: 0910-0435 7/31/2024
Administrative Procedures, Policies,
and Requirements.......................
Generic Clearance for the Collection of 0910-0796 7/31/2024
Qualitative Data on Tobacco Products
and Communications.....................
Survey of Drug Product Manufacturing, 0910-0899 7/31/2024
Processing, and Packing Facilities.....
Current Good Manufacturing Practices for 0910-0116 8/31/2024
Blood and Related Regulations for Blood
Components; and Requirements for Donor
Testing, Donor Notification and
``Lookback''...........................
New Animal Drugs for Investigational Use 0910-0117 8/31/2024
Regulations Under the Federal Import 0910-0212 8/31/2024
Milk Act...............................
Medical Device Reporting................ 0910-0437 8/31/2024
New Plant Varieties Intended for Food 0910-0583 8/31/2024
Use....................................
Guidance for Industry and FDA Staff; 0910-0594 8/31/2024
Class II Special Controls: Automated
Blood Cell Separator Device Operating
by Centrifugal or Filtration Separation
Principle..............................
Prescription Drug Advertisements........ 0910-0686 8/31/2024
Animal Food Labeling; Declaration of 0910-0721 8/31/2024
Certifiable Color Additives............
Survey on the Occurrence of Foodborne 0910-0744 8/31/2024
Illness Risk Factors in Selected Retail
and Food Service Facility Types........
Food and Cosmetic Export Certificates... 0910-0793 8/31/2024
National Agriculture and Food Defense 0910-0855 8/31/2024
Strategy Survey........................
Medical Product Communications That are 0910-0856 8/31/2024
Consistent With the Food and Drug
Administration Required Labeling--
Questions and Answers..................
Drug and Device Manufacturer 0910-0857 8/31/2024
Communications with Payors, Formulary
Committees, and Similar Entities
Questions and Answers..................
Study of Disclosures to Health Care 0910-0900 8/31/2024
Providers Regarding Data That Do Not
Support Unapproved Use of an Approved
Prescription Drug......................
Medical Conference Attendees' 0910-0901 8/31/2024
Observations About Prescription Drug
Promotion..............................
------------------------------------------------------------------------
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21386 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
