Agency Information Collection Activities: Submission for OMB Review; Comment Request, 22740 [2020-08651]
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22740
Federal Register / Vol. 85, No. 79 / Thursday, April 23, 2020 / Notices
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–262]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice; partial withdrawal.
AGENCY:
On Wednesday, April 15,
2020, the Centers for Medicare &
Medicaid Services (CMS) published a
notice entitled, ‘‘Agency Information
Collection Activities: Submission for
OMB Review; Comment Request.’’ That
notice invited public comments on two
separate information collection requests
specific to document identifiers: CMS–
10716 and CMS–R–262. Through the
publication of this document, we are
withdrawing the portion of the notice
requesting public comment on the
information collection request titled
‘‘CMS Plan Benefit Package (PBP) and
Formulary CY 2021.’’ Form number
CMS–R–262 (OMB control number
0938–0673).
DATES: The original comment period for
the document that published on April
15, 2020, remains in effect and ends
May 15, 2020.
SUPPLEMENTARY INFORMATION: In FR
document, 2020–07884, published on
April 15, 2020, (85 FR 21009), we are
withdrawing item 2 ‘‘CMS Plan Benefit
Package (PBP) and Formulary CY 2021’’
which begins on page 21010.
SUMMARY:
Dated: April 20, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–08651 Filed 4–22–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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Interpreting Sameness of Gene
Therapy Products Under the Orphan
Drug Regulations; Draft Guidance for
Industry; Extension of Comment
Period
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
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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
[Docket No. FDA–2019–D–5392]
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
extending the comment period for the
notice of availability entitled
‘‘Interpreting Sameness of Gene Therapy
Products Under the Orphan Drug
Regulations; Draft Guidance for
Industry’’ that appeared in the Federal
Register of January 30, 2020. The
Agency is taking this action to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the notice published January
30, 2020 (85 FR 5445). Submit either
electronic or written comments on the
draft guidance by July 28, 2020, to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–5392 for ‘‘Interpreting
Sameness of Gene Therapy Products
Under the Orphan Drug Regulations.’’
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.
• 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.’’ The
Agency will review this copy, including
the claimed confidential information, in
its 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.
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.
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 Office
of Communication, Outreach and
E:\FR\FM\23APN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Page 22740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08651]
[[Page 22740]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-262]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice; partial withdrawal.
-----------------------------------------------------------------------
SUMMARY: On Wednesday, April 15, 2020, the Centers for Medicare &
Medicaid Services (CMS) published a notice entitled, ``Agency
Information Collection Activities: Submission for OMB Review; Comment
Request.'' That notice invited public comments on two separate
information collection requests specific to document identifiers: CMS-
10716 and CMS-R-262. Through the publication of this document, we are
withdrawing the portion of the notice requesting public comment on the
information collection request titled ``CMS Plan Benefit Package (PBP)
and Formulary CY 2021.'' Form number CMS-R-262 (OMB control number
0938-0673).
DATES: The original comment period for the document that published on
April 15, 2020, remains in effect and ends May 15, 2020.
SUPPLEMENTARY INFORMATION: In FR document, 2020-07884, published on
April 15, 2020, (85 FR 21009), we are withdrawing item 2 ``CMS Plan
Benefit Package (PBP) and Formulary CY 2021'' which begins on page
21010.
Dated: April 20, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-08651 Filed 4-22-20; 8:45 am]
BILLING CODE 4120-01-P
