Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Cover Sheet, 22689-22690 [2014-09202]

Download as PDF 22689 Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices manufacturer’s batch number is used for temporarily identifying a batch of color additive until FDA issues a certification lot number and for identifying a certified batch during inspections. The manufacturer’s batch number also aids in tracing the disposal of a certified batch or a batch that has been denied certification for noncompliance with the color additive regulations. The manufacturer’s batch weight is used for assessing the certification fee. The batch weight also is used to account for the disposal of a batch of certified or certification-denied color additive. The batch weight can be used in a recall to determine whether all unused color additive in the batch has been recalled. The manufacturer’s name and address and the name and address of the person requesting certification are used to contact the person responsible should a question arise concerning compliance with the color additive regulations. Information on storage conditions pending certification is used to evaluate whether a batch of certified color additive is inadvertently or intentionally altered in a manner that would make the sample submitted for certification analysis unrepresentative of the batch. We check storage information during inspections. Information on intended uses for a batch of color additive is used to assure that a batch of certified color additive will be used in accordance with the requirements of its listing regulation. The statement of the fee on a certification request is used for accounting purposes so that a person requesting certification can be notified promptly of any discrepancies. In the Federal Register of February 6, 2014 (79 FR 7199), FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of 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 Total annual responses Average burden per response Total hours 80.21; Request for Certification ....................... 80.22; Sample to accompany request ............. 35 35 199 199 6,965 6,965 0.17 0.05 1,184 348 Total .......................................................... .............................. .............................. .............................. 0.22 1,532 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1 21 CFR section; activity Number of recordkeepers Number of records per recordkeeping Total annual records Average burden per recordkeeping Total hours 80.39; Record of Distribution ........................... 35 199 6,965 0.25 1,741 wreier-aviles on DSK5TPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate on our review of the certification requests received over the past 3 fiscal years (FY). The annual burden estimate for this information collection is 3,273 hours. The estimated reporting burden for this information collection is 1,532 hours and the estimated recordkeeping burden for this information collection is 1,741 hours. From FY 2011 to FY 2013, we processed an average of 6,954 responses (requests for certification of batches of color additives) per year. There were 35 different respondents, corresponding to an average of approximately 199 responses from each respondent per year. Using information from industry personnel, we estimate that an average of 0.22 hour per response is required for reporting (preparing certification requests and accompanying samples) and an average of 0.25 hour per response is required for recordkeeping. Our web-based Color Certification information system allows submitters to request color certification online, follow their submissions through the process, and obtain information on account status. The system sends back the VerDate Mar<15>2010 15:37 Apr 22, 2014 Jkt 232001 certification results electronically, allowing submitters to sell their certified color before receiving hard copy certificates. Any delays in the system result only from shipment of color additive samples to FDA’s Office of Cosmetics and Colors for analysis. SUMMARY: Dated: April 17, 2014. Leslie Kux, Assistant Commissioner for Policy. DATES: [FR Doc. 2014–09200 Filed 4–22–14; 8:45 am] ADDRESSES: BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0078] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00072 Fmt 4703 Sfmt 4703 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. Fax written comments on the collection of information by May 23, 2014. 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. FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\23APN1.SGM 23APN1 22690 Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices 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; Form FDA 3546 (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), as amended by Animal Drug User Fee Act (ADUFA) (Pub. L. 108–130), FDA has the authority to assess and collect for certain animal drug user fees. Because concurrent submission of user fees with applications and supplements is required, review of an application cannot begin until the fee is submitted. The types of fees that require a cover sheet are certain animal drug application fees and certain supplemental animal drug application fees. The ADUFA cover sheet (Form FDA 3546) is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application or supplement, to determine the amount of the fee required, and to assure that each animal drug user fee payment and each animal drug application for which payment is made is appropriately linked to the payment that is made. The form, when completed electronically, will result in the generation of a unique payment identification number used in tracking the payment. FDA will use the information collected to initiate administrative screening of new animal drug applications and supplements to determine if payment has been received. In the Federal Register of February 3, 2014 (79 FR 6199), FDA published a 60day 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 FD&C Act section amended by ADUFA FDA Form No. 740(a)(1) ....................... 3546 (Cover Sheet) .... 17 1 There Dated: April 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09202 Filed 4–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0090] Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: 1 time for each application. Total annual responses Average burden per response Total hours 17 1 17 are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to this collection of information are new animal drug applicants or manufacturers. Based on FDA’s database system, there are an estimated 173 manufacturers of products or sponsors of new animal drugs potentially subject to ADUFA. However, not all manufacturers or sponsors will have any submissions in a given year and some may have multiple submissions. The total number of annual responses is based on the average number of submissions received by FDA in fiscal years 2011–2013. The estimated hours per response are based on past FDA experience with the various submissions. The hours per response are based on the average of these estimates. wreier-aviles on DSK5TPTVN1PROD with NOTICES Number of responses per respondent Number of respondents Food and Drug Administration, HHS. VerDate Mar<15>2010 15:37 Apr 22, 2014 Jkt 232001 ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of the draft guidance entitled ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.’’ This draft guidance clarifies FDA’s current policy on balancing premarket and postmarket data collection during the Agency’s review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 22, 2014. ADDRESSES: An electronic copy of the guidance document is available for SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 download from the Internet. See the section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver Spring, MD 20993–0002 or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852– 1448. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver Spring, MD 20993–0002, 301– 796–5900 or Stephen Ripley, Center for SUPPLEMENTARY INFORMATION E:\FR\FM\23APN1.SGM 23APN1

Agencies

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22689-22690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0078]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
Act 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 May 23, 
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 0910-0539. 
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.

[[Page 22690]]


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; Form FDA 3546 (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), as amended by Animal Drug User Fee Act 
(ADUFA) (Pub. L. 108-130), FDA has the authority to assess and collect 
for certain animal drug user fees. Because concurrent submission of 
user fees with applications and supplements is required, review of an 
application cannot begin until the fee is submitted. The types of fees 
that require a cover sheet are certain animal drug application fees and 
certain supplemental animal drug application fees. The ADUFA cover 
sheet (Form FDA 3546) is designed to provide the minimum necessary 
information to determine whether a fee is required for the review of an 
application or supplement, to determine the amount of the fee required, 
and to assure that each animal drug user fee payment and each animal 
drug application for which payment is made is appropriately linked to 
the payment that is made. The form, when completed electronically, will 
result in the generation of a unique payment identification number used 
in tracking the payment. FDA will use the information collected to 
initiate administrative screening of new animal drug applications and 
supplements to determine if payment has been received.
    In the Federal Register of February 3, 2014 (79 FR 6199), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of       Number of responses     Total annual    Average burden
  FD&C Act section amended by ADUFA        FDA Form No.         respondents        per respondent         responses       per response     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1)...........................  3546 (Cover Sheet)....              17   1 time for each                     17                1               17
                                                                                application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are new animal drug 
applicants or manufacturers. Based on FDA's database system, there are 
an estimated 173 manufacturers of products or sponsors of new animal 
drugs potentially subject to ADUFA. However, not all manufacturers or 
sponsors will have any submissions in a given year and some may have 
multiple submissions. The total number of annual responses is based on 
the average number of submissions received by FDA in fiscal years 2011-
2013. The estimated hours per response are based on past FDA experience 
with the various submissions. The hours per response are based on the 
average of these estimates.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09202 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P
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