Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications, 46543-46544 [2019-19078]
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Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
These burden estimates reflect
adjustments since last OMB approval.
Previously we had based the estimated
number of respondents on the number
of individual production sites, however
we believe using the number of
registered organizations better reflects
the burden attributable to information
collection. This results in an overall
decrease to the collection.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19030 Filed 9–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2019–N–1517]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 October 4,
2019.
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 0910–0669. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
VerDate Sep<11>2014
19:08 Sep 03, 2019
Jkt 247001
collection of information to OMB for
review and clearance.
Abbreviated New Animal Drug
Applications—Section 512(b)(2) and
(n)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))
OMB Control Number 0910–0669—
Extension
Under section 512(b)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), any person may file an abbreviated
new animal drug application (ANADA)
seeking approval of a generic copy of an
approved new animal drug. The
information required to be submitted as
part of an ANADA is described in
section 512(n)(1) of the FD&C Act.
Among other things, an ANADA is
required to contain information to show
that the proposed generic drug is
bioequivalent to, and has the same
labeling as, the approved new animal
drug. We allow applicants to submit a
complete ANADA or to submit
information in support of an ANADA
for phased review. Applicants may
submit Form FDA 356v with a complete
ANADA or a phased-review submission
to ensure efficient and accurate
processing of information. We use the
information submitted, among other
things, to assess bioequivalence to the
originally approved drug and thus, the
safety and effectiveness of the generic
new animal drug.
We believe the demonstration of
bioequivalence required by the statute
does not need to be established on the
basis of in vivo studies (blood level
bioequivalence or clinical endpoint
bioequivalence) for soluble powder oral
dosage form products and certain Type
A medicated articles. We are adding to
this information collection applicant
requests to waive the requirement to
establish bioequivalence through in vivo
studies (biowaiver requests) for soluble
powder oral dosage form products or
certain Type A medicated articles based
upon either of two methods. We will
consider granting a biowaiver request if
it can be shown that the generic soluble
powder oral dosage form product or
Type A medicated article contains the
same active and inactive ingredient(s)
and is produced using the same
manufacturing processes as the
approved comparator product or article.
Alternatively, we will consider granting
a biowaiver request without direct
comparison to the pioneer product’s
formulation and manufacturing process
if it can be shown that the active
pharmaceutical ingredient(s) (API) is the
same as the pioneer product, is soluble,
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
46543
and that there are no ingredients in the
formulation likely to cause adverse
pharmacologic effects. We use the
information submitted by applicants in
the biowaiver request as the basis for
our decision whether to grant the
request.
Additionally, we have found that
various uses of veterinary master files
have increased the efficiency of the drug
development and drug review processes
for both us and the animal
pharmaceutical industry. A veterinary
master file is a repository for submission
to FDA’s Center for Veterinary Medicine
of confidential detailed information
about facilities, processes, or articles
used in the manufacturing, processing,
packaging, and storing of one or more
veterinary drugs. Veterinary master files
are used by the animal pharmaceutical
industry in support of information being
submitted for new animal drug
applications (NADAs), ANADAs,
investigational new animal drug (INAD)
files, and generic investigational new
animal drug (JINAD) files. In previous
information collection requests, we
included the time necessary to compile
and submit such information to
veterinary master files within the
burden estimates provided for
applications and amended applications
(for NADAs and INAD files) and
abbreviated applications and amended
abbreviated applications (for ANADAs
and JINAD files), respectively. We
recently combined the time necessary to
compile and submit such information to
veterinary master files within the
burden estimates provided in the
collection of information supporting
new animal drug applications (OMB
control number 0910–0032).
The reporting associated with
ANADAs and related submissions is
necessary to ensure that new animal
drugs are in compliance with section
512(b)(2) of the FD&C Act. As noted, we
use the information submitted, among
other things, to assess bioequivalence to
the originally approved drug and thus,
the safety and effectiveness of the
generic new animal drug.
Description of Respondents: The
respondents for this collection of
information are veterinary
pharmaceutical manufacturers.
In the Federal Register of April 18,
2019 (84 FR 16270), 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:
E:\FR\FM\04SEN1.SGM
04SEN1
46544
Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
ANADA .....................................................
Phased Review with Administrative
ANADA .................................................
Biowaiver request for soluble powder
oral dosage form product, using same
formulation/manufacturing process approach ...................................................
Biowaiver request for soluble powder
oral dosage form product, using same
API/solubility approach .........................
Biowaiver request for Type A medicated
article, using same formulation/manufacturing process approach ..................
Biowaiver request for Type A medicated
article, using same API/solubility approach ...................................................
Total ..................................................
1 There
Average
burden per
response
Total annual
responses
Total
hours
356v
18
1
18
159
2,862
356v
3
5
15
31.8
477
N/A
1
1
1
5
5
N/A
5
1
5
10
50
N/A
2
1
2
5
10
N/A
10
1
10
20
200
........................
........................
........................
51
........................
3,604
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records
of generic drug applications. We
estimate that we will receive 21 ANADA
submissions per year over the next 3
years and that 3 of those submissions
will request phased review. We estimate
that each applicant that uses the phased
review process will have approximately
five phased reviews per application. We
estimate that an applicant will take
approximately 159 hours to prepare
either an ANADA or the estimated five
ANADA phased review submissions
and the administrative ANADA. Our
estimates of the burden of biowaiver
requests for generic soluble powder oral
dosage form products and Type A
medicated articles differ based on the
type of product and the basis for the
request, as shown in table 1. We
estimate that an applicant will take
between 5 and 20 hours to prepare a
biowaiver request.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our previous estimate of
the number of respondents submitting
generic drug applications. However, as
discussed, the burden for this
information collection was increased by
265 hours and 18 responses since the
last OMB approval. This is due to
adding to this collection burden hours
and responses for biowaiver requests.
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FDA form No.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19078 Filed 9–3–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:08 Sep 03, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with safe and
sanitary processing and importing of
fish and fishery products.
DATES: Submit either electronic or
written comments on the collection of
information by November 4, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 4,
2019. The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
comments until 11:59 p.m. Eastern Time
at the end of November 4, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
E:\FR\FM\04SEN1.SGM
04SEN1
Agencies
[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46543-46544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-N-1517]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Abbreviated New
Animal Drug Applications
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 October
4, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0669.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
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.
Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))
OMB Control Number 0910-0669--Extension
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), any person may file an abbreviated new animal drug
application (ANADA) seeking approval of a generic copy of an approved
new animal drug. The information required to be submitted as part of an
ANADA is described in section 512(n)(1) of the FD&C Act. Among other
things, an ANADA is required to contain information to show that the
proposed generic drug is bioequivalent to, and has the same labeling
as, the approved new animal drug. We allow applicants to submit a
complete ANADA or to submit information in support of an ANADA for
phased review. Applicants may submit Form FDA 356v with a complete
ANADA or a phased-review submission to ensure efficient and accurate
processing of information. We use the information submitted, among
other things, to assess bioequivalence to the originally approved drug
and thus, the safety and effectiveness of the generic new animal drug.
We believe the demonstration of bioequivalence required by the
statute does not need to be established on the basis of in vivo studies
(blood level bioequivalence or clinical endpoint bioequivalence) for
soluble powder oral dosage form products and certain Type A medicated
articles. We are adding to this information collection applicant
requests to waive the requirement to establish bioequivalence through
in vivo studies (biowaiver requests) for soluble powder oral dosage
form products or certain Type A medicated articles based upon either of
two methods. We will consider granting a biowaiver request if it can be
shown that the generic soluble powder oral dosage form product or Type
A medicated article contains the same active and inactive ingredient(s)
and is produced using the same manufacturing processes as the approved
comparator product or article. Alternatively, we will consider granting
a biowaiver request without direct comparison to the pioneer product's
formulation and manufacturing process if it can be shown that the
active pharmaceutical ingredient(s) (API) is the same as the pioneer
product, is soluble, and that there are no ingredients in the
formulation likely to cause adverse pharmacologic effects. We use the
information submitted by applicants in the biowaiver request as the
basis for our decision whether to grant the request.
Additionally, we have found that various uses of veterinary master
files have increased the efficiency of the drug development and drug
review processes for both us and the animal pharmaceutical industry. A
veterinary master file is a repository for submission to FDA's Center
for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more veterinary drugs.
Veterinary master files are used by the animal pharmaceutical industry
in support of information being submitted for new animal drug
applications (NADAs), ANADAs, investigational new animal drug (INAD)
files, and generic investigational new animal drug (JINAD) files. In
previous information collection requests, we included the time
necessary to compile and submit such information to veterinary master
files within the burden estimates provided for applications and amended
applications (for NADAs and INAD files) and abbreviated applications
and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We recently combined the time necessary to compile and
submit such information to veterinary master files within the burden
estimates provided in the collection of information supporting new
animal drug applications (OMB control number 0910-0032).
The reporting associated with ANADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(2) of the FD&C Act. As noted, we use the information
submitted, among other things, to assess bioequivalence to the
originally approved drug and thus, the safety and effectiveness of the
generic new animal drug.
Description of Respondents: The respondents for this collection of
information are veterinary pharmaceutical manufacturers.
In the Federal Register of April 18, 2019 (84 FR 16270), 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:
[[Page 46544]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA................................................... 356v 18 1 18 159 2,862
Phased Review with Administrative ANADA................. 356v 3 5 15 31.8 477
Biowaiver request for soluble powder oral dosage form N/A 1 1 1 5 5
product, using same formulation/manufacturing process
approach...............................................
Biowaiver request for soluble powder oral dosage form N/A 5 1 5 10 50
product, using same API/solubility approach............
Biowaiver request for Type A medicated article, using N/A 2 1 2 5 10
same formulation/manufacturing process approach........
Biowaiver request for Type A medicated article, using N/A 10 1 10 20 200
same API/solubility approach...........................
-------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 51 .............. 3,604
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records of generic drug applications.
We estimate that we will receive 21 ANADA submissions per year over the
next 3 years and that 3 of those submissions will request phased
review. We estimate that each applicant that uses the phased review
process will have approximately five phased reviews per application. We
estimate that an applicant will take approximately 159 hours to prepare
either an ANADA or the estimated five ANADA phased review submissions
and the administrative ANADA. Our estimates of the burden of biowaiver
requests for generic soluble powder oral dosage form products and Type
A medicated articles differ based on the type of product and the basis
for the request, as shown in table 1. We estimate that an applicant
will take between 5 and 20 hours to prepare a biowaiver request.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our previous
estimate of the number of respondents submitting generic drug
applications. However, as discussed, the burden for this information
collection was increased by 265 hours and 18 responses since the last
OMB approval. This is due to adding to this collection burden hours and
responses for biowaiver requests.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19078 Filed 9-3-19; 8:45 am]
BILLING CODE 4164-01-P