Agency Information Collection Activities: Proposed Collection; Comment Request, 4184-4185 [2023-01215]

Download as PDF 4184 Federal Register / Vol. 88, No. 15 / Tuesday, January 24, 2023 / Notices USAGM Office of Contracts, 330 Independence Ave. SW, Washington, DC 20237. FOR FURTHER INFORMATION CONTACT: Khilena Adhin, Acquisition Policy Branch Chief, at conpolicy@usagm.gov, 202–920–2302. SUPPLEMENTARY INFORMATION: In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010, the U.S. Agency for Global Media (USAGM) is publishing this notice to advise the public of the availability of its FY 2022 Service Contract Analysis and FY 2021 Service Contract Inventory. They are available on the USAGM website, through the following link: https://www.usagm.gov/ ourwork/strategy-and-results/strategicpriorities/research-reports/servicecontract-inventory/. The service contract inventory provides information on service contract actions over $25,000 made in FY 2021. The information is organized by function to show how contracted resources are distributed throughout the Agency. The inventory has been developed in accordance with guidance on service contract inventories issued on November 5, 2010 and on December 19, 2011 by the Office of Management and Budget, Office of Federal Procurement Policy (OFPP). ADDRESSES: Dated: January 18, 2023. Armanda Matthews, Program Support Specialist. U.S. Agency for Global Media. [FR Doc. 2023–01322 Filed 1–23–23; 8:45 am] BILLING CODE 8610–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10844] Agency Information Collection Activities: Proposed Collection; Comment Request FOR FURTHER INFORMATION CONTACT: Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. Contents The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10844 Small Biotech Exception Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain AGENCY: SUMMARY: tkelley on DSK125TN23PROD with NOTICES extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by March 27, 2023. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: ll , Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. VerDate Sep<11>2014 19:17 Jan 23, 2023 Jkt 259001 William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Small Biotech Exception; Use: Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117–169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (the Act). In accordance with section 1192(d)(2) of the Act, the term ‘‘negotiation-eligible drug’’ excludes, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets the requirements for the exception for small biotech drugs (the ‘‘Small Biotech Exception’’). This information is required in order for CMS to accurately identify whether a given drug meets the criteria for the Small Biotech Exception in accordance with section 1192(d)(2) of the Act. To ensure that only covered Part D drugs that meet the requirements for the Small Biotech Exception are excluded from the term ‘‘negotiation-eligible drug,’’ a manufacturer that seeks the Small Biotech Exception for its covered Part D drug (‘‘Submitting Manufacturer’’) must submit information to CMS about the company and its products in order for the drug to be considered for the exception. If the Submitting Manufacturer seeks the Small Biotech Exception for a covered Part D drug it acquired after December 31, 2021, the Submitting Manufacturer must also submit information related to the separate entity that had the Medicare Coverage Gap Discount Program agreement for the drug on December 31, 2021. The Information Collection Request Form for the Small Biotech E:\FR\FM\24JAN1.SGM 24JAN1 Federal Register / Vol. 88, No. 15 / Tuesday, January 24, 2023 / Notices Exception must be submitted to CMS before CMS establishes the selected drug list for initial price applicability year 2026. Form Number: CMS–10844 (OMB control number: 0938–New); Frequency: Once; Affected Public: Private sector, Business or other forprofit; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 68.5. (For policy questions regarding this collection contact Corey Rosenberg at 410–786– 9763.) Dated: January 18, 2023. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2023–01215 Filed 1–23–23; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–E–0674] Determination of Regulatory Review Period for Purposes of Patent Extension; BYFAVO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BYFAVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by March 27, 2023. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 24, 2023. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing tkelley on DSK125TN23PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:17 Jan 23, 2023 Jkt 259001 system will accept comments until 11:59 p.m. Eastern Time at the end of March 27, 2023. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. 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– 2022–E–0674 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; BYFAVO.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 4185 • 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 § 10.20 (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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to E:\FR\FM\24JAN1.SGM 24JAN1

Agencies

[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4184-4185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01215]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10844]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by March 27, 2023.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __ , Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10844 Small Biotech Exception

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Small 
Biotech Exception; Use: Under the authority in sections 11001 and 11002 
of the Inflation Reduction Act of 2022 (Pub. L. 117-169), the Centers 
for Medicare & Medicaid Services (CMS) is implementing the Medicare 
Drug Price Negotiation Program, codified in sections 1191 through 1198 
of the Social Security Act (the Act). In accordance with section 
1192(d)(2) of the Act, the term ``negotiation-eligible drug'' excludes, 
with respect to the initial price applicability years 2026, 2027, and 
2028, a qualifying single source drug that meets the requirements for 
the exception for small biotech drugs (the ``Small Biotech 
Exception'').
    This information is required in order for CMS to accurately 
identify whether a given drug meets the criteria for the Small Biotech 
Exception in accordance with section 1192(d)(2) of the Act. To ensure 
that only covered Part D drugs that meet the requirements for the Small 
Biotech Exception are excluded from the term ``negotiation-eligible 
drug,'' a manufacturer that seeks the Small Biotech Exception for its 
covered Part D drug (``Submitting Manufacturer'') must submit 
information to CMS about the company and its products in order for the 
drug to be considered for the exception. If the Submitting Manufacturer 
seeks the Small Biotech Exception for a covered Part D drug it acquired 
after December 31, 2021, the Submitting Manufacturer must also submit 
information related to the separate entity that had the Medicare 
Coverage Gap Discount Program agreement for the drug on December 31, 
2021. The Information Collection Request Form for the Small Biotech

[[Page 4185]]

Exception must be submitted to CMS before CMS establishes the selected 
drug list for initial price applicability year 2026. Form Number: CMS-
10844 (OMB control number: 0938-New); Frequency: Once; Affected Public: 
Private sector, Business or other for-profit; Number of Respondents: 
10; Total Annual Responses: 10; Total Annual Hours: 68.5. (For policy 
questions regarding this collection contact Corey Rosenberg at 410-786-
9763.)

    Dated: January 18, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-01215 Filed 1-23-23; 8:45 am]
BILLING CODE 4120-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.