Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction, 47345 [2018-20317]

Download as PDF Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices Dated: September 14, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–20372 Filed 9–18–18; 8:45 am] U.S. Customs and Border Protection [1651–0029] DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities: Application for ForeignTrade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit Food and Drug Administration AGENCY: BILLING CODE 4120–01–P U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 30-Day notice and request for comments; extension of an existing collection of information. [Docket No. FDA–2018–D–3152] Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction AGENCY: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability’’ that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, September 11, 2018 (83 FR 45944), in FR Doc. 2018–19666, on page 45944, the following correction is made: On page 45944, in the first column, in the header of the document, and also in the third column under Instructions, ‘‘Docket No. FDA–2018–D–3151’’ is corrected to read ‘‘Docket No. FDA– 2018–D–3152’’. SUMMARY: Dated: September 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20317 Filed 9–18–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:09 Sep 18, 2018 Jkt 244001 The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted no later than October 19, 2018 to be assured of consideration. ADDRESSES: Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to dhsdeskofficer@ omb.eop.gov. SUMMARY: Food and Drug Administration, HHS ACTION: amozie on DSK3GDR082PROD with NOTICES1 DEPARTMENT OF HOMELAND SECURITY FOR FURTHER INFORMATION CONTACT: Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229–1177, Telephone number (202) 325–0056 or via email CBP_PRA@cbp.dhs.gov. Please note that the contact information provided here is solely for questions regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877–227–5511, (TTY) 1–800–877–8339, or CBP website at https://www.cbp .gov/. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 47345 Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (Volume 83 FR Page 23286) on May 18, 2018, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record. Overview of This Information Collection Title: Application for Foreign-Trade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit. OMB Number: 1651–0029. Form Numbers: 214, 214A, 214B, 214C, and 216. Type of Review: Extension (without change). Action: CBP proposes to extend the expiration date of this information collection with no change to the burden hours or to CBP Forms 214, 214A, 214B, 214C, and 216. Affected Public: Businesses. Abstract: Foreign trade zones (FTZs) are geographical enclaves located within the geographical limits of the United States but for tariff purposes are considered to be outside the United States. Imported merchandise may be brought into FTZs for storage, manipulation, manufacture or other processing and subsequent removal for exportation, consumption in the United States, or destruction. A company bringing goods into an FTZ has a choice of zone status (privileged/nonprivileged foreign, domestic, or zone- E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Page 47345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3152]


Postapproval Changes to Drug Substances; Draft Guidance for 
Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Postapproval Changes to Drug Substances; Draft Guidance for 
Industry; Availability'' that appeared in the Federal Register of 
September 11, 2018. The document announced a draft guidance that 
provides recommendations to holders of approved new drug applications, 
abbreviated new drug applications, new animal drug applications, 
abbreviated new animal drug applications, and holders of drug master 
files and veterinary master files who may want to make a change to the 
drug substance manufacturing process during the drug product 
application postapproval period. The document was published with the 
incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, 
September 11, 2018 (83 FR 45944), in FR Doc. 2018-19666, on page 45944, 
the following correction is made:
    On page 45944, in the first column, in the header of the document, 
and also in the third column under Instructions, ``Docket No. FDA-2018-
D-3151'' is corrected to read ``Docket No. FDA-2018-D-3152''.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20317 Filed 9-18-18; 8:45 am]
 BILLING CODE 4164-01-P

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