83 FR 47345 - Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 182 (September 19, 2018)

Page Range		47345-47345
FR Document		2018-20317

The Food and Drug Administration is correcting a notice entitled ``Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new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.

Federal Register, Volume 83 Issue 182 (Wednesday, September 19, 2018)

[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Page 47345]
From the Federal Register Online  [www.thefederalregister.org]
[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Postapproval Changes to Drug Substances; Draft Guidance for 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.

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

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entitled ``Postapproval Changes to Drug Substances; Draft Guidance for 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 The document announced a draft guidance that 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

Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices 47345

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

or CBP website at https://www.cbp manipulation, manufacture or other
2018–D–3152’’.
.gov/. processing and subsequent removal for
Dated: September 12, 2018. SUPPLEMENTARY INFORMATION: CBP exportation, consumption in the United
Leslie Kux, invites the general public and other States, or destruction. A company
Associate Commissioner for Policy. Federal agencies to comment on the bringing goods into an FTZ has a choice
[FR Doc. 2018–20317 Filed 9–18–18; 8:45 am] proposed and/or continuing information of zone status (privileged/non-
BILLING CODE 4164–01–P collections pursuant to the Paperwork privileged foreign, domestic, or zone-

VerDate Sep<11>2014 17:09 Sep 18, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1

Document Created: 2018-09-19 02:55:14
Document Modified: 2018-09-19 02:55:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; correction.
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.
FR Citation		83 FR 47345

83 FR 47345 - Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 182 (September 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration