82 FR 48093 - Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 198 (October 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 48093-48093 | |
| FR Document | 2017-22299 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Notices] [Page 48093] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22299] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, [email protected]. 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
![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48093
comment on the proposed collection of We therefore estimate the burden
information. No comments were associated with the information
received. collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual
Compounding outsourcing facility responses per burden per Total hours
respondents responses
respondent response
Electronic Submission of Registration Information Using
SPL Format ...................................................................... 62 1 62 4.5 279
Waiver Request From Electronic Submission of Registra-
tion Information ................................................................. 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 280
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that approximately 62 September 21, 2017 (82 FR 44185). The announcing the availability of a draft
outsourcing facilities (‘‘number of document announced the withdrawal of guidance for industry entitled ‘‘Post-
respondents’’ and ‘‘total annual approval of 27 abbreviated new drug Complete Response Letter Meetings
responses’’ in table 1, row 1) will applications (ANDAs) from multiple Between FDA and ANDA Applicants
annually submit to FDA registration applicants. The document was Under GDUFA.’’ This guidance is
information using the SPL format as published with the incorrect docket intended to clarify the criteria for
specified in the guidance, and that number. This document corrects that granting post-complete response letter
preparing and submitting this error. (CRL) meeting requests and the scope of
information will take approximately 4.5 discussions for granted meeting
FOR FURTHER INFORMATION CONTACT: Lisa
hours per registrant (‘‘average burden requests. This guidance provides
Granger, Office of Policy, Food and Drug
per response’’ in table 1, row 1). We procedures that will promote well-
Administration, 10903 New Hampshire
expect to receive no more than one managed post-CRL meetings and help
Ave., Bldg. 32, Rm. 3330, Silver Spring,
waiver request from the electronic ensure that such meetings are scheduled
MD 20993–0002, 301–796–9115,
submission process annually (‘‘number and conducted in accordance with the
lisa.granger@fda.hhs.gov.
of respondents’’ and ‘‘total annual time frames set forth in the GDUFA
responses’’ in table 1, row 2), and that SUPPLEMENTARY INFORMATION: In the
Reauthorization Performance Goals and
each request should take approximately Federal Register of Thursday, Program Enhancements Fiscal Years
1 hour to prepare and submit to us September 21, 2017, in FR Doc. 2017– 2018–2022 (GDUFA II Goals or
(‘‘average burden per response’’ in table 20107, on page 44185 the following Commitment Letter).
1, row 2). correction is made:
On page 44185, in the second column, DATES: Submit either electronic or
Dated: October 10, 2017. under the docket number FDA–2017–N– written comments on the draft guidance
Anna K. Abram, 5526 is corrected to read ‘‘FDA–2017– by December 15, 2017 to ensure that the
Deputy Commissioner for Policy, Planning, N–5226’’. Agency considers your comment on this
Legislation, and Analysis. draft guidance before it begins work on
Dated: October 11, 2017.
[FR Doc. 2017–22284 Filed 10–13–17; 8:45 am] the final version of the guidance.
Anna K. Abram,
BILLING CODE 4164–01–P ADDRESSES: You may submit comments
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
on any guidance at any time as follows:
DEPARTMENT OF HEALTH AND [FR Doc. 2017–22299 Filed 10–13–17; 8:45 am] Electronic Submissions
HUMAN SERVICES BILLING CODE 4164–01–P
Submit electronic comments in the
following way:
Food and Drug Administration
• Federal eRulemaking Portal:
DEPARTMENT OF HEALTH AND
[Docket No. FDA–2017–N–5226] https://www.regulations.gov. Follow the
HUMAN SERVICES
instructions for submitting comments.
Department of Health and Human Comments submitted electronically,
Food and Drug Administration
Services, Supply Service Center et al.; including attachments, to https://
Withdrawal of Approval of 27 [Docket No. FDA–2017–D–5928] www.regulations.gov will be posted to
Abbreviated New Drug Applications; the docket unchanged. Because your
Correction Post-Complete Response Letter
comment will be made public, you are
Meetings Between the Food and Drug
AGENCY: Food and Drug Administration, solely responsible for ensuring that your
Administration and Abbreviated New
HHS. comment does not include any
Drug Application Applicants Under the
ACTION: Notice; correction. confidential information that you or a
Generic Drug User Fee Act; Draft
third party may not wish to be posted,
ethrower on DSK3G9T082PROD with NOTICES
Guidance for Industry; Availability
SUMMARY: The Food and Drug such as medical information, your or
Administration is correcting a notice AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
entitled ‘‘Department of Health and HHS. confidential business information, such
Human Services, Supply Service Center ACTION: Notice of availability. as a manufacturing process. Please note
et al.; Withdrawal of Approval of 27 that if you include your name, contact
Abbreviated New Drug Applications’’ SUMMARY: The Food and Drug information, or other information that
that appeared in the Federal Register of Administration (FDA or Agency) is identifies you in the body of your
VerDate Sep<11>2014 16:59 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1](https://thefederalregister.org/doc/82_FR_48291/page/1.svg)
Document Created: 2017-10-14 01:42:27
Document Modified: 2017-10-14 01:42:27
| 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115, [email protected] | |
| FR Citation | 82 FR 48093 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR