81 FR 73116 - Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 205 (October 24, 2016)

Page Range		73116-73116
FR Document		2016-25603

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.

Federal Register, Volume 81 Issue 205 (Monday, October 24, 2016)

[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Page 73116]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

73116 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices

collection of information. No comments FDA estimates the burden of this
were received. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
[CDER] 1

Number of Total Average
Number of responses
21 CFR section annual burden per Total hours
respondents per responses response
respondent

320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 13 15 195 14 2,730
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 100 6 600 12 7,200
312.32(c)(1)(iv) IND Safety Reports .................................... 10 1 10 12 120

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
Total Average
Number of responses
21 CFR section annual burden per Total hours
respondents per responses response
respondent

320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 1 1 1 14 14
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 137 4 548 12 6,576
312.32(c)(1)(iv) IND Safety Reports .................................... 5 1.4 7 12 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. reauthorization of the Generic Drug User recommendations, FDA is extending the
Leslie Kux, Fee Amendments of 2012 (GDUFA). The comment period for the GDUFA
Associate Commissioner for Policy. Agency is taking this action to allow reauthorization draft recommendations
[FR Doc. 2016–25606 Filed 10–21–16; 8:45 am] interested persons the statutorily until November 16, 2016.
required 30 days to submit comments.
BILLING CODE 4164–01–P In addition, in FR Doc. 2016–23111,
Also, the document was published with
appearing on page 66035 in the Federal
an error in the SUPPLEMENTARY
INFORMATION section. This document
Register of Monday, September 26,
DEPARTMENT OF HEALTH AND
corrects that error. 2016, the following correction is made:
HUMAN SERVICES
DATES: FDA is extending the comment On page 66038, in the final paragraph
Food and Drug Administration period on the Generic Drug User Fee of the first column, the second sentence
[Docket No. FDA–2012–N–0882] recommendations published September is corrected to read: ‘‘Specifically, FDA
26, 2016 (81 FR 66035). Submit either would issue product-specific guidance
Generic Drug User Fees; Notice of electronic or written comments by identifying the methodology for
Public Meeting; Request for November 16, 2016. developing drugs and generating
Comments; Extension of Comment FOR FURTHER INFORMATION CONTACT: evidence needed to support ANDA
Period; Correction Derek Griffing, Center for Drug approval, for 90 percent of new
Evaluation and Research, Food and chemical entity new drug applications
AGENCY: Food and Drug Administration,
Drug Administration, 10903 New that are approved on or after October 1,
HHS.
Hampshire Ave., Bldg. 75, Rm. 1673, 2017, at least 2 years prior to the earliest
ACTION: Notice; extension of comment Silver Spring, MD 20993, 240–402–
period; correction. lawful filing date.’’
6980, email: GenericDrugPolicy@
fda.hhs.gov. Dated: October 18, 2016.
SUMMARY: The Food and Drug
Leslie Kux,
Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: In the
extension of the comment period and Federal Register of September 26, 2016, Associate Commissioner for Policy.
correcting a notice that appeared in the FDA published a request for comments [FR Doc. 2016–25603 Filed 10–21–16; 8:45 am]
Federal Register of Monday, September
sradovich on DSK3GMQ082PROD with NOTICES

on GDUFA reauthorization draft BILLING CODE 4164–01–P
26, 2016 (81 FR 66035). The document recommendations. The comment period
announced a public meeting entitled ends on November 7, 2016.
‘‘Generic Drug User Fees; Public Because the Agency posted the draft
Meeting; Request for Comments.’’ In recommendations on October 14, 2016,
that Federal Register notice, FDA and the statute requires a period of 30
requested comments on the draft days be provided for the public to
recommendations related to the provide comments on the draft

VerDate Sep<11>2014 17:42 Oct 21, 2016 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 E:\FR\FM\24OCN1.SGM 24OCN1

Document Created: 2016-10-21 23:45:54
Document Modified: 2016-10-21 23:45:54

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; extension of comment period; correction.
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.
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: [email protected]
FR Citation		81 FR 73116

81 FR 73116 - Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 205 (October 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration