Investigational COVID-19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance; Correction, 63277 [2020-22142]

Download as PDF Federal Register / Vol. 85, No. 195 / Wednesday, October 7, 2020 / Notices comments directly into the comment field or attach a file for lengthier comments. If there are difficulties submitting comments, contact the GSA Regulatory Secretariat Division at 202– 501–4755 or GSARegSec@gsa.gov. Instructions: All items submitted must cite Information Collection 9000– 0024, Buy American, Trade Agreements, and Duty-Free Entry. Comments received generally will be posted without change to https:// www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two-to-three days after submission to verify posting. FOR FURTHER INFORMATION CONTACT: Zenaida Delgado, Procurement Analyst, at telephone 202–969–7207, or zenaida.delgado@gsa.gov. SUPPLEMENTARY INFORMATION: A. OMB Control Number, Title, and Any Associated Form(s) 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry. B. Need and Uses This clearance covers the information that an offeror must submit in response to the requirements of the provisions and clauses in Federal Acquisition Regulation (FAR) part 25 that relate to the following: * The Buy American statute (41 U.S.C. chapter 83 and Executive Order 10582). * The Trade Agreements Act (19 U.S.C. 2501–2515), including the World Trade Organization Government Procurement Agreement and various free trade agreements. * The American Recovery and Reinvestment Act of 2009 (Pub. L. 111– 5) (Recovery Act). * Subchapters VIII and X of Chapter 98 of the Harmonized Tariff Schedule of the United States (19 U.S.C. 1202). a. 52.225–2, Buy American Certificate. This provision requires the offeror to identify in its proposal supplies that do not meet the definition of domestic end product. b. 52.225–4, Buy American—Free Trade Agreements—Israeli Trade Act Certificate. This provision requires a separate list of foreign products that are eligible under a trade agreement, and a list of all other foreign end products. c. 52.225–6, Trade Agreements Certificate. This provision requires the offeror to certify that all end products are either U.S.-made or designated country end products, except as listed in paragraph (b) of the provision. VerDate Sep<11>2014 17:21 Oct 06, 2020 Jkt 253001 Offerors are not allowed to provide other than a U.S.-made or designated country end product, unless the requirement is waived. d. 52.225–8, Duty-Free Entry. This clause requires contractors to notify the contracting officer when they purchase foreign supplies, in order to determine whether the supplies should be dutyfree. The notice shall identify the foreign supplies, estimate the amount of duty, and the country of origin. The contractor is not required to identify foreign supplies that are identical in nature to items purchased by the contractor or any subcontractor in connection with its commercial business, and segregation of these supplies to ensure use only on Government contracts containing dutyfree entry provisions is not economical or feasible. In addition, all shipping documents and containers must specify certain information to assure the dutyfree entry of the supplies. e. Construction provisions and clauses: • 52.225–9, Buy American—Construction Materials • 52.225–10, Notice of Buy American Requirement—Construction Materials • 52.225–11, Buy American-Construction Materials Under Trade Agreements • 52.225–12, Notice of Buy American Requirement—Construction Materials under Trade Agreements • 52.225–21, Required Use of American Iron, Steel and Manufactured Goods—Buy American—Construction Materials • 52.225–23, Required Use of American Iron, Steel and Manufactured Goods—Buy American—Construction Materials Under Trade Agreements The listed provisions and clauses provide that an offeror or contractor requesting to use foreign construction material due to unreasonable cost of domestic construction material shall provide adequate information to permit evaluation of the request. C. Annual Burden Respondents: 8,771. Total Annual Responses: 43,891. Total Burden Hours: 40,738. Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202–501–4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000–0024, Buy American, Trade Agreements, and Duty-Free Entry. 63277 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1137] Investigational COVID–19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that published in the Federal Register of September 21, 2020. The document announced the withdrawal of a final guidance for industry entitled ‘‘Investigational COVID–19 Convalescent Plasma,’’ which was issued in April 2020 and updated in May 2020. FDA withdrew the guidance because the Agency issued a new guidance for industry of the same title. The document was published with the incorrect docket number for the guidance for industry that was withdrawn. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: SUMMARY: Correction In the Federal Register of September 18, 2020 (85 FR 593120), appearing on page 59320 in FR Doc. 2020–20801, the following correction is made: On page 59320, in the third column, the Docket No. ‘‘FDA–2020–D–1825’’ is corrected to read ‘‘FDA–2020–D–1137.’’ Dated: October 1, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22142 Filed 10–6–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1720] William F. Clark, Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy. Labeling of Foods Comprised of or Containing Cultured Seafood Cells; Request for Information [FR Doc. 2020–22151 Filed 10–6–20; 8:45 am] AGENCY: BILLING CODE 6820–EP–P HHS. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM Food and Drug Administration, 07OCN1

Agencies

[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Page 63277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1137]


Investigational COVID-19 Convalescent Plasma; Guidance for 
Industry; Withdrawal of Guidance; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that published in the Federal Register of September 21, 2020. The 
document announced the withdrawal of a final guidance for industry 
entitled ``Investigational COVID-19 Convalescent Plasma,'' which was 
issued in April 2020 and updated in May 2020. FDA withdrew the guidance 
because the Agency issued a new guidance for industry of the same 
title. The document was published with the incorrect docket number for 
the guidance for industry that was withdrawn. This document corrects 
that error.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

Correction

    In the Federal Register of September 18, 2020 (85 FR 593120), 
appearing on page 59320 in FR Doc. 2020-20801, the following correction 
is made:
    On page 59320, in the third column, the Docket No. ``FDA-2020-D-
1825'' is corrected to read ``FDA-2020-D-1137.''

    Dated: October 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22142 Filed 10-6-20; 8:45 am]
BILLING CODE 4164-01-P
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