Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions, 28525-28526 [2014-11322]

Download as PDF 28525 Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare— Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: May 13, 2014. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–11380 Filed 5–15–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Fax written comments on the collection of information by June 16, 2014. DATES: 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. ADDRESSES: [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 FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration 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. SUMMARY: 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 (ADUFA) (Pub. L. 108–130) amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees 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. 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 February 25, 2014 (79 FR 10532) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden for this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR section; activity Average burden per response Total annual responses Total hours 740(d)(1)(A); significant barrier to innovation. 740(d)(1)(B); fees exceed cost ......... 740(d)(1)(C); free choice feeds ........ 740(d)(1)(D); minor use or minor species. 740(d)(1)(E); small business ............. Request for reconsideration of a decision. Request for review—(user fee appeal officer). 45 1 time for each application ............... 45 2 90 8 5 76 3.75 .................................................. 1 time for each application ............... 1 time for each application ............... 30 5 76 2 0.5 2 2 15 10 152 3 2 1 time for each application ............... 1 time for each application ............... 3 2 2 2 6 4 0 1 time for each application ............... 0 0 0 Total ........................................... ........................ ........................................................... ........................ ........................ 277 1 There EMCDONALD on DSK67QTVN1PROD with NOTICES 2 30 are no capital costs or operating and maintenance costs associated with this collection of information. minutes. Based on FDA’s database system, from fiscal years 2010 to 2012 there were an estimated 173 sponsors subject to ADUFA. However, not all sponsors will VerDate Mar<15>2010 20:20 May 15, 2014 Jkt 232001 have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the average PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 number of submission types received by FDA in fiscal years 2010 to 2012. E:\FR\FM\16MYN1.SGM 16MYN1 28526 Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices Dated: May 12, 2014. Leslie Kux, Assistant Commissioner for Policy. include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2014–11322 Filed 5–15–14; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0360] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Safety Communication Readership Survey 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 June 16, 2014. SUMMARY: 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 0910–0341. Also ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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. FDA Safety Communication (Formerly Known as Public Health Notification) Readership Survey—(OMB Control Number 0910–0341)—(Extension) Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 375(b)) gives FDA authority to disseminate information concerning suspected or imminent danger to public health by any regulated product. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) also authorizes FDA to conduct research relating to health information. FDA’s Center for Devices and Radiological Health (CDRH) carries out FDA’s regulatory responsibilities regarding medical devices and radiological products. CDRH must be able to effectively communicate risk to health care practitioners, patients, caregivers, and consumers when there is a real or suspected threat to the public’s health. CDRH uses safety communications to transmit information concerning these risks to user communities. Safety communications are released and available to organizations such as hospitals, nursing homes, hospices, home health care agencies, manufacturers, retail pharmacies, and other health care providers, as well as patients, caregivers, consumers, and patient advocacy groups. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to release safety communications. FDA seeks to evaluate the clarity, timeliness, and impact of safety communications by surveying a sample of recipients to determine the impact of safety communications on the knowledge of the recipients. Understanding how the target audiences view these publications will aid in determining what, if any, changes should be considered in their content, format, and method of dissemination. The collection of this data is an important step in determining how well CDRH is communicating risk. The results from this survey will emphasize the quality of the safety communications and customer satisfaction. This will enable us to better serve the public by improving the effectiveness of safety communications. We updated the title of the survey from ‘‘FDA Public Health Notification Readership Survey’’ to ‘‘FDA Safety Communication Readership Survey’’ to accurately reflect the information that is being collected. In the Federal Register of February 10, 2014 (79 FR 7677), 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 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Public Health Notification Readership Survey ..................... 300 3 900 0.17 153 EMCDONALD on DSK67QTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the Safety Communication program, it is estimated that an average of 3 collections will be conducted per year. The total burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey. Dated: May 12, 2014. DEPARTMENT OF HEALTH AND HUMAN SERVICES Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11326 Filed 5–15–14; 8:45 am] BILLING CODE 4160–01–P National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 20:20 May 15, 2014 Jkt 232001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28525-28526]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11322]


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

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 June 
16, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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 (ADUFA) 
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and 
requires FDA to assess and collect user fees 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.
    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 February 25, 2014 (79 FR 10532) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
   21 CFR section; activity        Number of      responses per    Total annual     burden per      Total hours
                                  respondents      respondent        responses       response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                   45  1 time for each               45               2              90
 barrier to innovation.                          application.
740(d)(1)(B); fees exceed cost               8  3.75............              30         \2\ 0.5              15
740(d)(1)(C); free choice                    5  1 time for each                5               2              10
 feeds.                                          application.
740(d)(1)(D); minor use or                  76  1 time for each               76               2             152
 minor species.                                  application.
740(d)(1)(E); small business..               3  1 time for each                3               2               6
                                                 application.
Request for reconsideration of               2  1 time for each                2               2               4
 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.
\2\ 30 minutes.

    Based on FDA's database system, from fiscal years 2010 to 2012 
there were an estimated 173 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 fiscal years 
2010 to 2012.


[[Page 28526]]


    Dated: May 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11322 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P
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