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