Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports, 74728-74729 [2014-29426]
Download as PDF
<![CDATA[
74728
Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Requirements for Submission of In
Vivo Bioequivalence Data—21 CFR
parts 314 and 320.
SUPPLEMENTARY INFORMATION:
OMB Control Number 0910–0630—
Extension
In the Federal Register of January 16,
2009 (74 FR 2849), the Agency
published a final rule revising FDA
regulations to require applicants to
submit data on all bioequivalence (BE)
studies, including studies that do not
meet passing bioequivalence criteria,
which are performed on a drug product
formulation submitted for approval
under an abbreviated new drug
application (ANDA), or in an
amendment or supplement to an ANDA
that contains BE studies. In the final
rule, FDA amended 314.94(a)(7)(i),
314.96(a)(1), 320.21(b)(1), and 314.97
(21 CFR 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97) to require an
ANDA applicant to submit information
from all BE studies, both passing and
nonpassing, conducted by the applicant
on the same drug product formulation
as that submitted for approval under an
ANDA, amendment, or supplement.
In table 1, FDA has estimated the
reporting burden associated with each
section of this requirement. FDA
believes that the majority of additional
BE studies will be reported in ANDAs
(submitted under 314.94), rather than
supplements (reported in 314.97)
because it is unlikely than an ANDA
holder will conduct BE studies with a
drug after the drug has been approved.
With respect to the reporting of
additional BE studies in amendments
(submitted under 314.96), this should
also account for a small number of
reports because most BE studies will be
conducted on a drug prior to the
submission of the ANDA and will be
reported in the ANDA itself.
FDA estimates applicants will require
approximately 120 hours of staff time to
prepare and submit each additional
complete BE study report and
approximately 60 hours of staff time for
each additional BE summary report. The
Agency believes that a complete report
will be required approximately 20
percent of the time, while a summary
will suffice approximately 80 percent of
the time. Based on a weighted-average
calculation using the information
presented previously in this document,
the submission of each additional BE
study is expected to take 72 hours of
staff time ([120 × 0.2] + [60 × 0.8]).
In the Federal Register of June 26,
2014 (79 FR 36320), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
314.94(a)(7) .........................................................................
314.96(a)(1) .........................................................................
314.97 ..................................................................................
84
1
1
1
1
1
84
1
1
72
72
72
6,048
72
72
Total ..............................................................................
........................
........................
........................
........................
6,192
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[FR Doc. 2014–29425 Filed 12–15–14; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by January 15,
2015.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0284. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1409]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
19:38 Dec 15, 2014
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Road; COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Notice.
Jkt 235001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Records and Reports Concerning
Experiences With Approved New
Animal Drugs: Adverse Event Reports
on Paper Forms FDA 1932, 1932a, and
2301—21 CFR 514.80; OMB Control
Number 0910–0284—Extension
Section 512(l) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(l) and 514.80 (21 CFR
514.80) of FDA regulations require
applicants of approved new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) to report adverse drug
experiences and product/manufacturing
defects (see 514.80)(b)). Additionally,
section 571(e)(3) of the FD&C Act (21
U.S.C. 360ccc(e)(3)) requires that
E:\FR\FM\16DEN1.SGM
16DEN1
74729
Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
applicants for conditional approval of
new animal drugs (CNADAs) maintain
adequate reports and records of adverse
drug experiences and product/
manufacturing defects as applicable
under section 512(l) of the FD&C Act.
The continuous monitoring of
approved NADAs, ANADAs, and
CNADAs affords the primary means by
which FDA obtains information
regarding potential problems with the
safety and efficacy of marketed
approved new animal drugs as well as
potential product/manufacturing
problems. Post-approval marketing
surveillance is important because data
previously submitted to FDA may not be
adequate as animal drug effects can
change over time and less apparent
effects may take years to manifest.
Under 514.80(d), an applicant must
report adverse drug experiences and
product/manufacturing defects on Form
FDA 1932, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product
Defect Report.’’ Periodic drug
experience reports and special drug
experience reports must be
accompanied by a completed Form FDA
2301, ‘‘Transmittal of Periodic Reports
and Promotional Material for New
Animal Drugs,’’ (see 514.80). Form FDA
1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report,’’ allows for
voluntary reporting of adverse drug
experiences or product/manufacturing
defects.
In 2010, electronic versions of Forms
FDA 1932 and 1932a were incorporated
into the FDA Safety Reporting Portal.
This electronic system is used for
collecting, submitting, and processing
adverse event reports and other safety
information for all FDA regulated
products. Burden for the electronic
version of these forms is accounted for
under OMB control number 0910–0645.
This approval request accounts for the
collection of information using existing
paper Forms FDA 1932, 1932a, and
2301 and is currently approved under
OMB control number 0910–0284. FDA
estimates that, at this time,
approximately 50 percent of the
respondents utilize paper forms for
submitting this information. We expect
this number to decrease as more
respondents avail themselves of the
FDA Safety Reporting Portal.
In the Federal Register of September
29, 2014 (79 FR 58355), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section/section of the FD&C act
FDA
form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
514.80(b)(1), 514.80(b)(2)(i) and (ii),
514.80(b)(3) ..........................................
Voluntary reporting FDA Form 1932a for
the public ..............................................
514.80(b)(4) .............................................
514.80(b)(5)(i) ..........................................
514.80(b)(5)(ii) .........................................
514.80(b)(5)(iii) .........................................
1932
22
81.05
1,783
1
1,783
1932a
2301
2301
2301
2301
197
200
200
200
190
1
8.11
0.57
20.12
0.1
197
1,622
114
4,024
20
1
16
2
2
2
197
25,952
228
8,048
40
Total Hours .......................................
........................
........................
........................
........................
........................
36,248
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
514.80(e) ..............................................................................
1 There
646
Total annual
records
7.20
4651
Average
burden per
recordkeeping
14
Total hours
65,117
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29426 Filed 12–15–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1842]
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Crabmeat—Fresh and Frozen—
Adulteration With Filth, Involving the
Presence of Escherichia coli;
Compliance Policy Guide; Draft
Guidance for Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
VerDate Sep<11>2014
19:38 Dec 15, 2014
Jkt 235001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
announcing the availability of a draft
guidance for FDA staff entitled
‘‘Compliance Policy Guide Crabmeat—
Fresh and Frozen—Adulteration with
Filth, Involving the Presence of
Escherichia coli.’’ The draft Compliance
Policy Guide (CPG), when finalized,
will update the previously issued ‘‘CPG
Crabmeat—Fresh and Frozen—
Adulteration with Filth, Involving the
Presence of the Organism Escherichia
coli.’’ This revised draft provides
guidance for FDA staff on the level of
Escherichia coli (E. coli) in crabmeat at
which we may consider the crabmeat to
be adulterated with filth.
Although you can comment on
any guidance at any time (see 21 CFR
DATES:
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74728-74729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1409]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Records and Reports
Concerning Experiences With Approved New Animal Drugs: Adverse Event
Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
15, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0284.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Records and Reports Concerning Experiences With Approved New Animal
Drugs: Adverse Event Reports on Paper Forms FDA 1932, 1932a, and 2301--
21 CFR 514.80; OMB Control Number 0910-0284--Extension
Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360b(l) and 514.80 (21 CFR 514.80) of FDA
regulations require applicants of approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects (see
514.80)(b)). Additionally, section 571(e)(3) of the FD&C Act (21 U.S.C.
360ccc(e)(3)) requires that
[[Page 74729]]
applicants for conditional approval of new animal drugs (CNADAs)
maintain adequate reports and records of adverse drug experiences and
product/manufacturing defects as applicable under section 512(l) of the
FD&C Act.
The continuous monitoring of approved NADAs, ANADAs, and CNADAs
affords the primary means by which FDA obtains information regarding
potential problems with the safety and efficacy of marketed approved
new animal drugs as well as potential product/manufacturing problems.
Post-approval marketing surveillance is important because data
previously submitted to FDA may not be adequate as animal drug effects
can change over time and less apparent effects may take years to
manifest.
Under 514.80(d), an applicant must report adverse drug experiences
and product/manufacturing defects on Form FDA 1932, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.''
Periodic drug experience reports and special drug experience reports
must be accompanied by a completed Form FDA 2301, ``Transmittal of
Periodic Reports and Promotional Material for New Animal Drugs,'' (see
514.80). Form FDA 1932a, ``Veterinary Adverse Drug Reaction, Lack of
Effectiveness or Product Defect Report,'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects.
In 2010, electronic versions of Forms FDA 1932 and 1932a were
incorporated into the FDA Safety Reporting Portal. This electronic
system is used for collecting, submitting, and processing adverse event
reports and other safety information for all FDA regulated products.
Burden for the electronic version of these forms is accounted for under
OMB control number 0910-0645. This approval request accounts for the
collection of information using existing paper Forms FDA 1932, 1932a,
and 2301 and is currently approved under OMB control number 0910-0284.
FDA estimates that, at this time, approximately 50 percent of the
respondents utilize paper forms for submitting this information. We
expect this number to decrease as more respondents avail themselves of
the FDA Safety Reporting Portal.
In the Federal Register of September 29, 2014 (79 FR 58355), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/section of the FD&C act FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(1), 514.80(b)(2)(i) and (ii), 514.80(b)(3).... 1932 22 81.05 1,783 1 1,783
Voluntary reporting FDA Form 1932a for the public....... 1932a 197 1 197 1 197
514.80(b)(4)............................................ 2301 200 8.11 1,622 16 25,952
514.80(b)(5)(i)......................................... 2301 200 0.57 114 2 228
514.80(b)(5)(ii)........................................ 2301 200 20.12 4,024 2 8,048
514.80(b)(5)(iii)....................................... 2301 190 0.1 20 2 40
-----------------------------------------------------------------------------------------------
Total Hours......................................... .............. .............. .............. .............. .............. 36,248
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
514.80(e)....................... 646 7.20 4651 14 65,117
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29426 Filed 12-15-14; 8:45 am]
BILLING CODE 4164-01-P
