Collecting and Providing 702(b) Portions of Food and Drug Administration Official Samples-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 3302-3303 [2022-01143]
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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES1
Annual Hours: 46,575. (For policy
questions regarding this collection
contact William Long at 410–786–7927.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Application and
Triennial Re-application to Be a
Qualified Entity to Receive Medicare
Data for Performance Measurement;
Use: The Patient Protection and
Affordable Care Act (ACA) was enacted
on March 23, 2010 (Pub. L. 111–148).
ACA amends section 1874 of the Social
Security Act by adding a new
subsection (e) to make standardized
extracts of Medicare claims data under
Parts A, B, and D available to qualified
entities to evaluate the performance of
providers of services and suppliers. This
is the application needed to determine
an organization’s eligibility as a
qualified entity. The information from
the collection is used by CMS to
determine whether an organization
meets the criteria required to be
considered a qualified entity to receive
Medicare claims data under ACA
Section 10332. CMS evaluates the
organization’s eligibility in terms of
organizational and governance
capabilities, addition of claims data
from other sources, and data privacy
and security. This collection covers the
application through which
organizations provide information to
CMS to determine whether they will be
approved as a qualified entity. This
collection also covers the triennial reapplication (CMS–10596; 0938–1317)
through which organizations provide
information to CMS to determine
whether they are approved to continue
as a qualified entity. Form Number:
CMS–10394 (OMB control number:
0938–1144); Frequency: Occasionally;
Affected Public: Not-for-profits
institutions and Business or other forprofits; Number of Respondents: 30;
Total Annual Responses: 30; Total
Annual Hours: 3,800. (For policy
questions regarding this collection
contact Kari A. Gaare at 410–786–8612.)
Dated: January 18, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–01183 Filed 1–20–22; 8:45 am]
BILLING CODE 4120–01–P
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17:39 Jan 20, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0593]
Collecting and Providing 702(b)
Portions of Food and Drug
Administration Official Samples—
Questions and Answers; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry and FDA staff
entitled ‘‘Collecting and Providing
702(b) Portions of FDA Official
Samples—Questions and Answers.’’
This draft guidance is intended to assist
industry and FDA staff with issues and
questions related to the requirements for
FDA to collect and provide a part of an
official sample of an article to any
person named on the label of the article,
or the owner thereof, or his attorney or
agent.
DATES: Submit either electronic or
written comments on the draft guidance
by February 22, 2022 to ensure that we
consider your comment on this draft
guidance before we begin work on the
final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
PO 00000
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Fmt 4703
Sfmt 4703
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–D–0593 for ‘‘Collecting and
Providing 702(b) Portions and of FDA
Official Samples—Questions and
Answers.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
E:\FR\FM\21JAN1.SGM
21JAN1
Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Operational Policy, Office of
Regulatory Affairs, Food and Drug
Administration, Element Building,
12420 Parklawn Dr., Rockville, MD
20852. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
jspears on DSK121TN23PROD with NOTICES1
Chris Henderson, Office of Regulatory
Affairs, Food and Drug Administration,
Element Building, 12420 Parklawn Dr.,
Rockville, MD 20857 240–402–8186,
Christopher.henderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Collecting and Providing
702(b) Portions of FDA Official
Samples—Questions and Answers.’’
Section 702 of the FD&C Act (21 U.S.C.
372) authorizes FDA to conduct
examinations and investigations and to
collect samples. Under section 702(b) of
the FD&C Act, when FDA collects a
sample of a food, drug, or cosmetic for
analysis, FDA must, upon request,
provide a part of such official sample for
examination or analysis by any person
named on the label of the article, or the
owner thereof, or his attorney or agent.
Additionally, FDA was authorized to
establish, by regulation, reasonable
exceptions to, and impose reasonable
terms and conditions relating to, the
requirement to collect and provide a
702(b) portion of an official sample to
the owner, as necessary for the proper
administration of the provisions of the
FD&C Act. FDA’s regulation at 21 CFR
2.10 was issued to establish those
reasonable exceptions, and terms and
conditions, and to implement section
702(b) of the FD&C Act.
This draft guidance is intended to
assist industry and FDA staff with
issues and questions related to the
requirements for FDA to collect and
VerDate Sep<11>2014
17:39 Jan 20, 2022
Jkt 256001
provide portions of official samples
under section 702(b) of the FD&C Act
and its implementing regulation in 21
CFR 2.10.
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 ‘‘Collecting and Providing 702(b)
Portions of FDA Official Samples—
Questions and Answers.’’ 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
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01143 Filed 1–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1137, FDA–
2020–D–1138, FDA–2020–D–0987]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
SUMMARY:
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3303
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on January 21, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the name of the guidance
document that the comments address
and the docket number for the guidance
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3302-3303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01143]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0593]
Collecting and Providing 702(b) Portions of Food and Drug
Administration Official Samples--Questions and Answers; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Collecting and Providing 702(b) Portions of FDA Official Samples--
Questions and Answers.'' This draft guidance is intended to assist
industry and FDA staff with issues and questions related to the
requirements for FDA to collect and provide a part of an official
sample of an article to any person named on the label of the article,
or the owner thereof, or his attorney or agent.
DATES: Submit either electronic or written comments on the draft
guidance by February 22, 2022 to ensure that we consider your comment
on this draft guidance before we begin work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-D-0593 for ``Collecting and Providing 702(b) Portions and of
FDA Official Samples--Questions and Answers.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[[Page 3303]]
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Operational Policy, Office of Regulatory Affairs, Food
and Drug Administration, Element Building, 12420 Parklawn Dr.,
Rockville, MD 20852. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20857 240-402-8186,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Collecting and Providing 702(b) Portions of
FDA Official Samples--Questions and Answers.'' Section 702 of the FD&C
Act (21 U.S.C. 372) authorizes FDA to conduct examinations and
investigations and to collect samples. Under section 702(b) of the FD&C
Act, when FDA collects a sample of a food, drug, or cosmetic for
analysis, FDA must, upon request, provide a part of such official
sample for examination or analysis by any person named on the label of
the article, or the owner thereof, or his attorney or agent.
Additionally, FDA was authorized to establish, by regulation,
reasonable exceptions to, and impose reasonable terms and conditions
relating to, the requirement to collect and provide a 702(b) portion of
an official sample to the owner, as necessary for the proper
administration of the provisions of the FD&C Act. FDA's regulation at
21 CFR 2.10 was issued to establish those reasonable exceptions, and
terms and conditions, and to implement section 702(b) of the FD&C Act.
This draft guidance is intended to assist industry and FDA staff
with issues and questions related to the requirements for FDA to
collect and provide portions of official samples under section 702(b)
of the FD&C Act and its implementing regulation in 21 CFR 2.10.
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 ``Collecting
and Providing 702(b) Portions of FDA Official Samples--Questions and
Answers.'' 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
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01143 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P
