Agency Information Collection Activities: Submission for OMB Review; Comment Request, 22740 [2020-08651]

Download as PDF 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 lotter on DSKBCFDHB2PROD with NOTICES Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Extension of Comment Period Food and Drug Administration, HHS.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: VerDate Sep<11>2014 19:28 Apr 22, 2020 Jkt 250001 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 23APN1

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.

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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

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