Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 57558-57559 [2014-22808]

Download as PDF 57558 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden hours Type of respondent Form name Public health agency or organization Fellowship Management System Host Site. Fellowship Management System Application. Fellowship Management System Directory. 394 1 85/60 558 1,961 1 40/60 1,307 1,382 1 15/60 346 .......................................................... ........................ ........................ ........................ 2,211 Fellowship applicants ........................ Fellowship alumni* ............................ Total ........................................... * Some alumni are deceased or cannot be located. Response burden assumes response from an individual responding alumnus, on average, every three years (which is a likely overestimate of frequency). Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2014–22752 Filed 9–24–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs. DATES: Submit electronic or written comments on the collection of information by November 24, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:25 Sep 24, 2014 Jkt 232001 Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) SUPPLEMENTARY INFORMATION: [Docket No. FDA–2010–N–0155] AGENCY: Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Veterinary Feed Directive—21 CFR 558; OMB Control Number 0910–0363— Extension With the passage of the Animal Drug Availability Act, Congress enacted legislation establishing a new class of restricted feed use drugs, VFD drugs, which may be distributed without involving state pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (21 CFR 558.6) was tailored to the unique circumstances relating to the distribution of medicated feeds. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute, and records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost effectively as possible. On December 12, 2013, FDA published a proposed rule in the Federal Register (78 FR 75515) intended to improve the efficiency of FDA’s VFD program. The provisions included in the proposed rule were based on stakeholder input received in response to solicitations for public comment, including an advance notice of proposed rulemaking on March 29, 2010 (75 FR 15387), and draft text of proposed amendments to the current VFD regulations on April 13, 2012 (77 FR 22247). While FDA intends to finalize the VFD rulemaking in 2015, the current E:\FR\FM\25SEN1.SGM 25SEN1 57559 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices information collection request supporting the program expires on December 31, 2014. At this time, the burden for this information collection remains unchanged. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section Number of responses per respondent Total annual responses 558.6(a)(3) through (a)(5) ...................... 558.6(d)(1)(i) through (d)(1)(iii) .............. 558.6(d)(1)(iv) ........................................ 558.6(d)(2) ............................................. 514.1(b)(9) ............................................. 15,000 300 20 1,000 1 25 1 1 5 1 375,000 300 20 5000 1 Total ................................................ .............................. .............................. .............................. 1 There Average burden per response 0.25 0.25 0.25 0.25 (15 (15 (15 (15 Total hours minutes) minutes) minutes) minutes) 3.00 93,750 75 5 1,250 3 .............................. 95,083 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2 —ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 558.6(c)(1) through (c)(4) ...................... 558.6(e)(1) through (e)(4) ...................... 112,500 5,000 10 75 1,125,000 375,000 0.0167 (1 minute) 0.0167 (1 minute) 18,788 6,263 Total ................................................ .............................. .............................. .............................. .............................. 25,051 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of time required for record preparation and maintenance is based on Agency communication with industry and Agency records and experience. Dated: September 19, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22808 Filed 9–24–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1344] Policy Clarification for Fluoroscopic Equipment Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Policy Clarification for Fluoroscopic Equipment Requirements.’’ This draft guidance describes FDA’s intent to clarify the application of certain aspects of the performance standard requirements for fluoroscopic equipment when manufacturers comply with certain mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:25 Sep 24, 2014 Jkt 232001 International Electrotechnical Commission (IEC) standards. 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 December 24, 2014. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Policy Clarification for Fluoroscopic Equipment Requirements’’ 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. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to http:// 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Donald Miller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993–0002, 301–796–3299. SUPPLEMENTARY INFORMATION: I. Background The draft guidance document, ‘‘Policy Clarification for Fluoroscopic Equipment Requirements’’ was developed to describe FDA’s intent to clarify the application of certain aspects of the performance standard requirements in 21 CFR 1020.32 for fluoroscopic equipment when the manufacturer has complied with certain IEC standards. FDA believes that a declaration of conformity with the applicable IEC standard and the applicable measure(s) set forth in this guidance as part of the 510(k) submission for their device will sufficiently address the concerns intended to be addressed by certain parts of the requirements of § 1020.32, such that the public health is adequately protected. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57558-57559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22808]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting and recordkeeping 
requirements for distribution and use of Veterinary Feed Directive 
(VFD) drugs and animal feeds containing VFD drugs.

DATES: Submit electronic or written comments on the collection of 
information by November 24, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Veterinary Feed Directive--21 CFR 558; OMB Control Number 0910-0363--
Extension

    With the passage of the Animal Drug Availability Act, Congress 
enacted legislation establishing a new class of restricted feed use 
drugs, VFD drugs, which may be distributed without involving state 
pharmacy laws. Although controls on the distribution and use of VFD 
drugs are similar to those for prescription drugs regulated under 
section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(f)), the implementing VFD regulation (21 CFR 558.6) was tailored to 
the unique circumstances relating to the distribution of medicated 
feeds. All distributors of medicated feed containing VFD drugs must 
notify FDA of their intent to distribute, and records must be 
maintained of the distribution of all medicated feeds containing VFD 
drugs. The VFD regulation ensures the protection of public health while 
enabling animal producers to obtain and use needed drugs as efficiently 
and cost effectively as possible.
    On December 12, 2013, FDA published a proposed rule in the Federal 
Register (78 FR 75515) intended to improve the efficiency of FDA's VFD 
program. The provisions included in the proposed rule were based on 
stakeholder input received in response to solicitations for public 
comment, including an advance notice of proposed rulemaking on March 
29, 2010 (75 FR 15387), and draft text of proposed amendments to the 
current VFD regulations on April 13, 2012 (77 FR 22247).
    While FDA intends to finalize the VFD rulemaking in 2015, the 
current

[[Page 57559]]

information collection request supporting the program expires on 
December 31, 2014. At this time, the burden for this information 
collection remains unchanged.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)...............................             15,000                 25            375,000  0.25 (15 minutes)             93,750
558.6(d)(1)(i) through (d)(1)(iii).......................                300                  1                300  0.25 (15 minutes)                 75
558.6(d)(1)(iv)..........................................                 20                  1                 20  0.25 (15 minutes)                  5
558.6(d)(2)..............................................              1,000                  5               5000  0.25 (15 minutes)              1,250
514.1(b)(9)..............................................                  1                  1                  1               3.00                  3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total................................................  .................  .................  .................  .................             95,083
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2 --Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4)...............................            112,500                 10          1,125,000  0.0167 (1 minute)             18,788
558.6(e)(1) through (e)(4)...............................              5,000                 75            375,000  0.0167 (1 minute)              6,263
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total................................................  .................  .................  .................  .................             25,051
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of time required for record preparation and 
maintenance is based on Agency communication with industry and Agency 
records and experience.

    Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22808 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P