82 FR 32827 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		32827-32828
FR Document		2017-14998

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 32827-32828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14998]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
Act Waivers and Reductions

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 0910-0540. 
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, 10A63, 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 Fees and Fee Waivers and Reductions OMB Control Number 
0910-0540--Extension

    Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L. 
108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which 
requires that FDA assess and collect user fees with respect to new 
animal drug applications for certain applications, products, 
establishments, and sponsors. It also requires the Agency to grant a 
waiver from, or a reduction of, those fees in certain circumstances. 
Thus, to implement this statutory provision of ADUFA, FDA developed a 
guidance entitled ``Guidance for Industry: Animal Drug User Fees and 
Fee Waivers and Reductions.'' This document provides guidance on the 
types of fees FDA is authorized to collect under ADUFA, and how to 
request waivers and reductions from FDA's animal drug user fees. 
Further, this guidance also describes the types of fees and fee waivers 
and reductions; what information FDA recommends be submitted in support 
of a request for a fee waiver or reduction; how to submit such a 
request; and FDA's process for reviewing requests. FDA uses the 
information submitted by respondents to determine whether to grant the 
requested fee waiver or reduction.
    Respondents to this collection of information are new animal drug 
sponsors. Requests for waivers or reductions may be submitted by a 
person paying any of the animal drug user fees assessed, including 
application fees, product fees, establishment fees, or sponsor fees.
    In the  Federal Register of October 17, 2016 (81 FR 71506), 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:

[[Page 32828]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
  FD&C act section/activity       Number of      responses per    Total annual    Average burden    Total hours
                                 respondents      respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                  55  1 time for each               55  2..............             110
 barrier to innovation.                         application.
740(d)(1)(B); fees exceed                   8  3.75............              30  .5 (30 minutes)              15
 cost.
740(d)(1)(C); free choice                   5  1 time for each                5  2..............              10
 feeds.                                         application.
740(d)(1)(D); minor use or                 69  1 time for each               69  2..............             138
 minor species.                                 application.
740(d)(1)(E); small business.               1  1 time for each                1  2..............               2
                                                application.
Request for reconsideration                 1  1 time for each                1  2..............               2
 of a decision.                                 application.
Request for review (user fee                0  1 time for each                0  0..............               0
 appeal officer).                               application.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............             277
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's database system, from fiscal year (FY) 2014 to 2016 
there were an estimated 177 sponsors subject to ADUFA. However, not all 
sponsors will have any submissions in a given year and some may have 
multiple submissions. The total number of waiver requests is based on 
the average number of submission types received by FDA in FY 2014 to 
2016. The burden has not changed since the last OMB approval.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14998 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P

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:

VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

32828 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FD&C act section/activity responses per burden per Total hours
respondents responses
respondent response

740(d)(1)(A); significant barrier to innovation 55 1 time for each appli- 55 2 ................................ 110
cation.
740(d)(1)(B); fees exceed cost ..................... 8 3.75 ........................... 30 .5 (30 minutes) .......... 15
740(d)(1)(C); free choice feeds .................... 5 1 time for each appli- 5 2 ................................ 10
cation.
740(d)(1)(D); minor use or minor species .... 69 1 time for each appli- 69 2 ................................ 138
cation.
740(d)(1)(E); small business ........................ 1 1 time for each appli- 1 2 ................................ 2
cation.
Request for reconsideration of a decision .... 1 1 time for each appli- 1 2 ................................ 2
cation.
Request for review (user fee appeal officer) 0 1 time for each appli- 0 0 ................................ 0
cation.

Total ....................................................... ........................ ................................... ........................ ................................... 277
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA’s database system, from ADDRESSES: To ensure that comments on an FDA-approved RDRC (§ 361.1(d)(7)).
fiscal year (FY) 2014 to 2016 there were the information collection are received, The type of research that may be
an estimated 177 sponsors subject to OMB recommends that written undertaken with a radiopharmaceutical
ADUFA. However, not all sponsors will comments be faxed to the Office of drug must be intended to obtain basic
have any submissions in a given year Information and Regulatory Affairs, information and not to carry out a
and some may have multiple OMB, Attn: FDA Desk Officer, FAX: clinical trial for safety or efficacy. The
submissions. The total number of 202–395–7285, or emailed to oira_ types of basic research permitted are
waiver requests is based on the average submission@omb.eop.gov. All specified in the regulation, and include
number of submission types received by comments should be identified with the studies of metabolism, human
FDA in FY 2014 to 2016. The burden OMB control number 0910–0053. Also physiology, pathophysiology, or
has not changed since the last OMB include the FDA docket number found biochemistry.
approval. in brackets in the heading of this Section 361.1(c)(2) requires that each
Dated: July 12, 2017. document. RDRC shall select a chairman, who shall
Anna K. Abram, FOR FURTHER INFORMATION CONTACT:
sign all applications, minutes, and
Jonnalynn Capezutto, Office of reports of the committee. Each
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. Operations, Food and Drug committee shall meet at least once each
Administration, Three White Flint quarter in which research activity has
[FR Doc. 2017–14998 Filed 7–17–17; 8:45 am]
North, 10A63, 11601 Landsdown St., been authorized or conducted. Minutes
BILLING CODE 4164–01–P
North Bethesda, MD 20852, 301–796– shall be kept and shall include the
3794, PRAStaff@fda.hhs.gov. numerical results of votes on protocols
DEPARTMENT OF HEALTH AND involving use in human subjects. Under
SUPPLEMENTARY INFORMATION: In § 361.1(c)(3), each RDRC shall submit an
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA annual report to FDA. The annual report
has submitted the following proposed shall include the names and
Food and Drug Administration collection of information to OMB for qualifications of the members of, and of
[Docket No. FDA–2010–N–0583] review and clearance. any consultants used by, the RDRC,
Agency Information Collection Radioactive Drug Research Committees using Form FDA 2914, and a summary
Activities; Submission for Office of of each study conducted during the
OMB Control Number 0910–0053— preceding year, using Form FDA 2915.
Management and Budget Review; Extension
Comment Request; Radioactive Drug Under § 361.1(d)(5), each investigator
Research Committees Under sections 201, 505, and 701 of shall obtain the proper consent required
the Federal Food, Drug, and Cosmetic under the regulations. Each female
AGENCY: Food and Drug Administration, Act (21 U.S.C. 321, 355, and 371), FDA research subject of childbearing
HHS. has the authority to issue regulations potential must state in writing that she
ACTION: Notice. governing the use of radioactive drugs is not pregnant, or on the basis of a
for basic scientific research. Section pregnancy test be confirmed as not
SUMMARY: The Food and Drug 361.1 (21 CFR 361.1) sets forth specific pregnant.
Administration (FDA or we) is regulations regarding the establishment Under § 361.1(d)(8), the investigator
announcing that a proposed collection and composition of Radioactive Drug shall immediately report to the RDRC all
sradovich on DSK3GMQ082PROD with NOTICES

of information has been submitted to the Research Committees (RDRCs) and their adverse effects associated with use of
Office of Management and Budget role in approving and monitoring basic the drug, and the committee shall then
(OMB) for review and clearance under research studies utilizing report to FDA all adverse reactions
the Paperwork Reduction Act of 1995. radiopharmaceuticals. No basic research probably attributed to the use of the
DATES: Fax written comments on the study involving any administration of a radioactive drug.
collection of information by August 17, radioactive drug to research subjects is Section 361.1(f) sets forth labeling
2017. permitted without the authorization of requirements for radioactive drugs.

VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

Document Created: 2018-10-24 11:23:43
Document Modified: 2018-10-24 11:23:43

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, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation		82 FR 32827

82 FR 32827 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions

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