Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet, 32826-32827 [2017-14997]

Download as PDF 32826 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices or a combination product, and which FDA medical product Agency Center (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health) will regulate it, if it is a non-combination product, or will have the primary jurisdiction for the premarket review and regulation of the product, if it is a combination product. There are two ways that a sponsor can receive such feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor’s product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–2) and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR part 3, and OCP has issued a guidance about this process (see ‘‘How to Write a Request for Designation’’ at https://www.fda.gov/ RegulatoryInformation/Guidances/ ucm126053.htm). A second more flexible option is for a sponsor to submit an inquiry to OCP to receive a preliminary jurisdictional assessment, which is not binding. Many sponsors seek to utilize the flexibility of more approachable ways to interact with OCP and the medical product Agency Centers to obtain feedback from the Agency before submitting a marketing application to the Agency. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of this process, which will now be called the ‘‘Pre-Request for Designation (Pre-RFD) Program.’’ This draft guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD. This draft guidance describes how to prepare a Pre-RFD. The guidance provides recommendations regarding the information that should be submitted in a Pre-RFD request and procedures that should be followed for meetings or conference calls between OCP, the Centers, and industry representatives or sponsors. The proposed collections of information are necessary to allow the Agency to receive Pre-RFD requests in order to implement this voluntary submission program. In the Federal Register of January 13, 2017 (82 FR 4351), FDA published a 60day notice requesting public comment on the proposed collection of information. Although two comments were received, they were not responsive to the four collection of information topics solicited and therefore will not be discussed. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pre-RFD Submissions ............................................................................. Pre-RFD Meetings ................................................................................... 136 136 1 1 136 136 12 1 1,632 136 Total .................................................................................................. .................... .................... .................... .................... 1,768 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–15005 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3GMQ082PROD with NOTICES [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, Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 7726, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: HHS. ACTION: 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 oira_ submission@omb.eop.gov. 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. Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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: 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 E:\FR\FM\18JYN1.SGM 18JYN1 32827 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 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 FD&C act section/ description FDA form No. 740(a)(1); Animal Drug User Fee cover sheet. FDA 3546 ........................... 1 There 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 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 Food and Drug Administration, HHS. sradovich on DSK3GMQ082PROD with NOTICES ACTION: Number of responses per respondent 21 Total annual responses 1 21 Average burden per response Total hours 1 21 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. AGENCY: Number of respondents Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 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 oira_ submission@omb.eop.gov. 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, 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. 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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: E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32826-32827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, 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.

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

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