82 FR 32826 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

Page Range		32826-32827
FR Document		2017-14997

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.

Federal Register, Volume 82 Issue 136 (Tuesday, July 18, 2017)

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32826-32827]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0600]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
Cover Sheet

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 August 
17, 2017.

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 0910-0539. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 11601 Landsdown 
St., North Bethesda, MD 20852, 301-796-7726, [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.

Animal Drug User Fee Cover Sheet OMB Control Number 0910-0539--
Extension

    Under section 740 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 379j-12), FDA has the authority to assess and 
collect application fees from each person who submits certain new 
animal drug applications or certain supplemental animal drug 
applications. The Animal Drug User Fee cover sheet (Form FDA 3546) is 
designed to collect the minimum necessary information to determine 
whether a fee is required for the review of an application or 
supplement or whether an application fee waiver was granted, to 
determine the amount of the fee required, and to assure that each 
animal drug user fee payment is appropriately linked to the

[[Page 32827]]

animal drug application for which payment is made. The form, when 
completed electronically, will result in the generation of a unique 
payment identification number used by FDA to track the payment. FDA's 
Center for Veterinary Medicine and FDA's Office of Management will use 
the information collected to initiate the administrative screening of 
new animal drug applications and supplements to determine whether the 
payment has been received.
    Description of Respondents: Respondents to this collection of 
information are new animal drug applicants.
    In the Federal Register of October 21, 2016 (81 FR 72810), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments. FDA estimates the 
burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
       FD&C act section/ description                FDA form No.             Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1); Animal Drug User Fee cover       FDA 3546....................              21               1              21               1              21
 sheet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with new 
animal drug applications and supplemental animal drug applications and 
the average number of Animal Drug User Fee cover sheets submitted 
during fiscal years 2013-2015. We estimate 21 respondents will each 
submit a cover sheet (Form FDA 3546) for a total of 21 responses. We 
calculate a reporting burden of 1 hour per response, for a total of 21 
hours. The burden hours are increased. The overall increase in burden 
hours (by 4 hours) is due to the normal variation in the number of 
Animal Drug User Fee cover sheets submitted to FDA.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14997 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P

32826 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices

or a combination product, and which flexible option is for a sponsor to submit teleconferences and meetings in relation
FDA medical product Agency Center an inquiry to OCP to receive a to a Pre-RFD.
(Center for Drug Evaluation and preliminary jurisdictional assessment, This draft guidance describes how to
Research, Center for Biologics which is not binding. prepare a Pre-RFD. The guidance
Evaluation and Research, or Center for Many sponsors seek to utilize the provides recommendations regarding
Devices and Radiological Health) will flexibility of more approachable ways to the information that should be
regulate it, if it is a non-combination interact with OCP and the medical submitted in a Pre-RFD request and
product, or will have the primary product Agency Centers to obtain procedures that should be followed for
jurisdiction for the premarket review feedback from the Agency before meetings or conference calls between
and regulation of the product, if it is a submitting a marketing application to OCP, the Centers, and industry
combination product. the Agency. Over time, these informal representatives or sponsors.
There are two ways that a sponsor can
methods of obtaining feedback have The proposed collections of
receive such feedback from OCP. One
become increasingly customary with information are necessary to allow the
option is to submit an RFD to receive a
sponsors, and for some, even preferable Agency to receive Pre-RFD requests in
formal, binding determination for the
sponsor’s product with respect to to the formal RFD process. Accordingly, order to implement this voluntary
classification and/or center assignment FDA is enhancing the transparency and submission program.
that may be changed under conditions consistency of this process, which will In the Federal Register of January 13,
specified in section 563 of the Federal now be called the ‘‘Pre-Request for 2017 (82 FR 4351), FDA published a 60-
Food, Drug, and Cosmetic Act (21 U.S.C. Designation (Pre-RFD) Program.’’ day notice requesting public comment
360bbb–2) and 21 CFR 3.9 in the This draft guidance describes this on the proposed collection of
regulations. The RFD process is codified structured process with clear information. Although two comments
in 21 CFR part 3, and OCP has issued recommendations for sponsors wishing were received, they were not responsive
a guidance about this process (see ‘‘How to submit Pre-RFDs. It also provides the to the four collection of information
to Write a Request for Designation’’ at process for review of Pre-RFDs by FDA topics solicited and therefore will not be
https://www.fda.gov/ staff, the general timeframes for discussed.
RegulatoryInformation/Guidances/ sponsors to receive feedback from OCP, FDA estimates the burden of this
ucm126053.htm). A second more and the process for scheduling collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent

Pre-RFD Submissions ............................................................................. 136 1 136 12 1,632
Pre-RFD Meetings ................................................................................... 136 1 136 1 136

Total .................................................................................................. .................... .................... .................... .................... 1,768
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 12, 2017. information has been submitted to the SUPPLEMENTARY INFORMATION: In
Anna K. Abram, Office of Management and Budget compliance with 44 U.S.C. 3507, FDA
Deputy Commissioner for Policy, Planning, (OMB) for review and clearance under has submitted the following proposed
Legislation, and Analysis. the Paperwork Reduction Act of 1995. collection of information to OMB for
[FR Doc. 2017–15005 Filed 7–17–17; 8:45 am] DATES: Fax written comments on the review and clearance.
BILLING CODE 4164–01–P collection of information by August 17, Animal Drug User Fee Cover Sheet
2017. OMB Control Number 0910–0539—
ADDRESSES: To ensure that comments on Extension
DEPARTMENT OF HEALTH AND the information collection are received,
HUMAN SERVICES Under section 740 of the Federal
OMB recommends that written Food, Drug, and Cosmetic Act (the
Food and Drug Administration comments be faxed to the Office of FD&C Act) (21 U.S.C. 379j–12), FDA has
Information and Regulatory Affairs, the authority to assess and collect
[Docket No. FDA–2010–N–0600] OMB, Attn: FDA Desk Officer, FAX: application fees from each person who
202–395–7285, or emailed to oira_ submits certain new animal drug
Agency Information Collection submission@omb.eop.gov. All applications or certain supplemental
Activities; Submission for Office of comments should be identified with the animal drug applications. The Animal
Management and Budget Review; OMB control number 0910–0539. Also Drug User Fee cover sheet (Form FDA
Comment Request; Animal Drug User include the FDA docket number found 3546) is designed to collect the
Fee Cover Sheet in brackets in the heading of this minimum necessary information to
sradovich on DSK3GMQ082PROD with NOTICES

document. determine whether a fee is required for
AGENCY: Food and Drug Administration,
HHS. FOR FURTHER INFORMATION CONTACT: Ila the review of an application or
ACTION: Notice. S. Mizrachi, Office of Operations, Food supplement or whether an application
and Drug Administration, Three White fee waiver was granted, to determine the
SUMMARY: The Food and Drug Flint North, 11601 Landsdown St., amount of the fee required, and to
Administration (FDA) is announcing North Bethesda, MD 20852, 301–796– assure that each animal drug user fee
that a proposed collection of 7726, PRAStaff@fda.hhs.gov. payment is appropriately linked to the

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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32827

animal drug application for which collected to initiate the administrative In the Federal Register of October 21,
payment is made. The form, when screening of new animal drug 2016 (81 FR 72810), FDA published a
completed electronically, will result in applications and supplements to 60-day notice requesting public
the generation of a unique payment determine whether the payment has comment on the proposed collection of
identification number used by FDA to been received. information. FDA received no
track the payment. FDA’s Center for Description of Respondents: comments. FDA estimates the burden of
Veterinary Medicine and FDA’s Office Respondents to this collection of this collection of information as follows:
of Management will use the information information are new animal drug
applicants.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
FD&C act section/ Number of Total annual
FDA form No. responses per burden per Total hours
description respondents responses
respondent response

740(a)(1); Animal Drug User FDA 3546 ........................... 21 1 21 1 21
Fee cover sheet.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates in table 1 are based on information has been submitted to the respect to new animal drug applications
our experience with new animal drug Office of Management and Budget for certain applications, products,
applications and supplemental animal (OMB) for review and clearance under establishments, and sponsors. It also
drug applications and the average the Paperwork Reduction Act of 1995. requires the Agency to grant a waiver
number of Animal Drug User Fee cover DATES: Fax written comments on the from, or a reduction of, those fees in
sheets submitted during fiscal years collection of information by August 17, certain circumstances. Thus, to
2013–2015. We estimate 21 respondents 2017. implement this statutory provision of
will each submit a cover sheet (Form ADDRESSES: To ensure that comments on ADUFA, FDA developed a guidance
FDA 3546) for a total of 21 responses. the information collection are received, entitled ‘‘Guidance for Industry: Animal
We calculate a reporting burden of 1 OMB recommends that written Drug User Fees and Fee Waivers and
hour per response, for a total of 21 comments be faxed to the Office of Reductions.’’ This document provides
hours. The burden hours are increased. Information and Regulatory Affairs, guidance on the types of fees FDA is
The overall increase in burden hours (by OMB, Attn: FDA Desk Officer, FAX: authorized to collect under ADUFA, and
4 hours) is due to the normal variation 202–395–7285, or emailed to oira_ how to request waivers and reductions
in the number of Animal Drug User Fee submission@omb.eop.gov. All from FDA’s animal drug user fees.
cover sheets submitted to FDA. comments should be identified with the Further, this guidance also describes the
Dated: July 12, 2017. OMB control number 0910–0540. Also types of fees and fee waivers and
Anna K. Abram, include the FDA docket number found reductions; what information FDA
Deputy Commissioner for Policy, Planning, in brackets in the heading of this recommends be submitted in support of
Legislation, and Analysis. document. a request for a fee waiver or reduction;
[FR Doc. 2017–14997 Filed 7–17–17; 8:45 am]
how to submit such a request; and
FOR FURTHER INFORMATION CONTACT: Ila
FDA’s process for reviewing requests.
BILLING CODE 4164–01–P S. Mizrachi, Office of Operations, Food FDA uses the information submitted by
and Drug Administration, Three White respondents to determine whether to
Flint North, 10A63, 11601 Landsdown grant the requested fee waiver or
DEPARTMENT OF HEALTH AND St., North Bethesda, MD 20852, 301–
HUMAN SERVICES reduction.
796–7726, PRAStaff@fda.hhs.gov.
Respondents to this collection of
Food and Drug Administration SUPPLEMENTARY INFORMATION: In
information are new animal drug
compliance with 44 U.S.C. 3507, FDA sponsors. Requests for waivers or
[Docket No. FDA–2007–N–0037] has submitted the following proposed reductions may be submitted by a
collection of information to OMB for person paying any of the animal drug
Agency Information Collection review and clearance.
Activities; Submission for Office of user fees assessed, including application
Management and Budget Review; Animal Drug User Fees and Fee fees, product fees, establishment fees, or
Comment Request; Animal Drug User Waivers and Reductions OMB Control sponsor fees.
Fee Act Waivers and Reductions Number 0910–0540—Extension In the Federal Register of October 17,
AGENCY: Food and Drug Administration, Enacted on November 18, 2003, the 2016 (81 FR 71506), FDA published a
HHS. Animal Drug User Fee Act (Pub. L. 108– 60-day notice requesting public
130) amended the Federal Food, Drug, comment on the proposed collection of
ACTION: Notice. information. FDA received no
and Cosmetic Act (the FD&C Act) by
SUMMARY: The Food and Drug adding section 740 of the FD&C Act (21 comments.
sradovich on DSK3GMQ082PROD with NOTICES

Administration (FDA) is announcing U.S.C 379j–12), which requires that FDA estimates the burden of this
that a proposed collection of FDA assess and collect user fees with collection of information as follows:

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Document Created: 2018-10-24 11:25:12
Document Modified: 2018-10-24 11:25:12

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.
Dates		Fax written comments on the collection of information by August 17, 2017.
Contact		Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation		82 FR 32826

82 FR 32826 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration