Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction, 73116 [2016-25603]

Download as PDF 73116 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN [CDER] 1 Number of respondents 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 320.31(d) Bioavailability and Bioequivalence Safety Reports .................................................................................. 312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 312.32(c)(1)(iv) IND Safety Reports .................................... 13 100 10 15 6 1 195 600 10 14 12 12 2,730 7,200 120 Total (CDER) ................................................................ ........................ ........................ ........................ ........................ 10,050 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN [CBER] 1 Number of respondents 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 320.31(d) Bioavailability and Bioequivalence Safety Reports .................................................................................. 312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 312.32(c)(1)(iv) IND Safety Reports .................................... 1 137 5 1 4 1.4 1 548 7 14 12 12 14 6,576 84 Total (CBER) ................................................................ ........................ ........................ ........................ ........................ 6,674 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25606 Filed 10–21–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0882] Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. Notice; extension of comment period; correction. ACTION: The Food and Drug Administration (FDA) is announcing the extension of the comment period and correcting a notice that appeared in the Federal Register of Monday, September 26, 2016 (81 FR 66035). The document announced a public meeting entitled ‘‘Generic Drug User Fees; Public Meeting; Request for Comments.’’ In that Federal Register notice, FDA requested comments on the draft recommendations related to the sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:42 Oct 21, 2016 Jkt 241001 reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The Agency is taking this action to allow interested persons the statutorily required 30 days to submit comments. Also, the document was published with an error in the SUPPLEMENTARY INFORMATION section. This document corrects that error. DATES: FDA is extending the comment period on the Generic Drug User Fee recommendations published September 26, 2016 (81 FR 66035). Submit either electronic or written comments by November 16, 2016. FOR FURTHER INFORMATION CONTACT: Derek Griffing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993, 240–402– 6980, email: GenericDrugPolicy@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of September 26, 2016, FDA published a request for comments on GDUFA reauthorization draft recommendations. The comment period ends on November 7, 2016. Because the Agency posted the draft recommendations on October 14, 2016, and the statute requires a period of 30 days be provided for the public to provide comments on the draft PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 recommendations, FDA is extending the comment period for the GDUFA reauthorization draft recommendations until November 16, 2016. In addition, in FR Doc. 2016–23111, appearing on page 66035 in the Federal Register of Monday, September 26, 2016, the following correction is made: On page 66038, in the final paragraph of the first column, the second sentence is corrected to read: ‘‘Specifically, FDA would issue product-specific guidance identifying the methodology for developing drugs and generating evidence needed to support ANDA approval, for 90 percent of new chemical entity new drug applications that are approved on or after October 1, 2017, at least 2 years prior to the earliest lawful filing date.’’ Dated: October 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25603 Filed 10–21–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\24OCN1.SGM 24OCN1

Agencies

[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Page 73116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0882]


Generic Drug User Fees; Notice of Public Meeting; Request for 
Comments; Extension of Comment Period; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period; correction.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
extension of the comment period and correcting a notice that appeared 
in the Federal Register of Monday, September 26, 2016 (81 FR 66035). 
The document announced a public meeting entitled ``Generic Drug User 
Fees; Public Meeting; Request for Comments.'' In that Federal Register 
notice, FDA requested comments on the draft recommendations related to 
the reauthorization of the Generic Drug User Fee Amendments of 2012 
(GDUFA). The Agency is taking this action to allow interested persons 
the statutorily required 30 days to submit comments. Also, the document 
was published with an error in the SUPPLEMENTARY INFORMATION section. 
This document corrects that error.

DATES: FDA is extending the comment period on the Generic Drug User Fee 
recommendations published September 26, 2016 (81 FR 66035). Submit 
either electronic or written comments by November 16, 2016.

FOR FURTHER INFORMATION CONTACT: Derek Griffing, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993, 240-402-
6980, email: GenericDrugPolicy@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 26, 
2016, FDA published a request for comments on GDUFA reauthorization 
draft recommendations. The comment period ends on November 7, 2016.
    Because the Agency posted the draft recommendations on October 14, 
2016, and the statute requires a period of 30 days be provided for the 
public to provide comments on the draft recommendations, FDA is 
extending the comment period for the GDUFA reauthorization draft 
recommendations until November 16, 2016.
    In addition, in FR Doc. 2016-23111, appearing on page 66035 in the 
Federal Register of Monday, September 26, 2016, the following 
correction is made:
    On page 66038, in the final paragraph of the first column, the 
second sentence is corrected to read: ``Specifically, FDA would issue 
product-specific guidance identifying the methodology for developing 
drugs and generating evidence needed to support ANDA approval, for 90 
percent of new chemical entity new drug applications that are approved 
on or after October 1, 2017, at least 2 years prior to the earliest 
lawful filing date.''

    Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25603 Filed 10-21-16; 8:45 am]
 BILLING CODE 4164-01-P