Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction, 48093 [2017-22299]

Download as PDF 48093 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices comment on the proposed collection of information. No comments were received. We therefore estimate the burden associated with the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Electronic Submission of Registration Information Using SPL Format ...................................................................... Waiver Request From Electronic Submission of Registration Information ................................................................. Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. 1 62 4.5 279 1 1 1 1 1 ........................ ........................ ........................ ........................ 280 September 21, 2017 (82 FR 44185). The document announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The document was published with the incorrect docket number. This document corrects that error. Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115, lisa.granger@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, September 21, 2017, in FR Doc. 2017– 20107, on page 44185 the following correction is made: On page 44185, in the second column, under the docket number FDA–2017–N– 5526 is corrected to read ‘‘FDA–2017– N–5226’’. FOR FURTHER INFORMATION CONTACT: Dated: October 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–22284 Filed 10–13–17; 8:45 am] BILLING CODE 4164–01–P Electronic Submissions BILLING CODE 4164–01–P 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 Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2017–N–5226] Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction Food and Drug Administration, HHS. ethrower on DSK3G9T082PROD with NOTICES Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications’’ that appeared in the Federal Register of SUMMARY: VerDate Sep<11>2014 16:59 Oct 13, 2017 Jkt 244001 announcing the availability of a draft guidance for industry entitled ‘‘PostComplete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.’’ This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote wellmanaged post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018–2022 (GDUFA II Goals or Commitment Letter). DATES: Submit either electronic or written comments on the draft guidance by December 15, 2017 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: [FR Doc. 2017–22299 Filed 10–13–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Total hours are no capital costs or operating and maintenance costs associated with this collection of information. We estimate that approximately 62 outsourcing facilities (‘‘number of respondents’’ and ‘‘total annual responses’’ in table 1, row 1) will annually submit to FDA registration information using the SPL format as specified in the guidance, and that preparing and submitting this information will take approximately 4.5 hours per registrant (‘‘average burden per response’’ in table 1, row 1). We expect to receive no more than one waiver request from the electronic submission process annually (‘‘number of respondents’’ and ‘‘total annual responses’’ in table 1, row 2), and that each request should take approximately 1 hour to prepare and submit to us (‘‘average burden per response’’ in table 1, row 2). AGENCY: Average burden per response Total annual responses 62 Total .............................................................................. 1 There Number of responses per respondent Number of respondents Compounding outsourcing facility Food and Drug Administration [Docket No. FDA–2017–D–5928] Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Page 48093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5226]


Department of Health and Human Services, Supply Service Center et 
al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; 
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 ``Department of Health and Human Services, Supply Service 
Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug 
Applications'' that appeared in the Federal Register of September 21, 
2017 (82 FR 44185). The document announced the withdrawal of approval 
of 27 abbreviated new drug applications (ANDAs) from multiple 
applicants. The document was published with the incorrect docket 
number. This document corrects that error.

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

SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, 
September 21, 2017, in FR Doc. 2017-20107, on page 44185 the following 
correction is made:
    On page 44185, in the second column, under the docket number FDA-
2017-N-5526 is corrected to read ``FDA-2017-N-5226''.

    Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22299 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P

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