Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008, 5463-5465 [2013-01446]

Download as PDF Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices indicated that there was not enough information provided about the design and methodology of the pretests and the studies to effectively comment on the collection of information. In response, the information collection is for a broad spectrum of pretests and studies using a variety of methodologies and is dependent on the material being tested and the target audience. Each separate collection and pretest will be submitted for OMB review and approval prior to 5463 the collection or pretest being released to the public. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity Individual In-Depth Interviews ........... General Public Focus Group Interviews. Intercept Interviews: Central Location. Intercept Interviews: Telephone 2 ..... Self-Administered Surveys ................ Gatekeeper Reviews ......................... Omnibus Surveys .............................. Total annual responses Average burden per response Total hours 360 144 1 1 360 144 0.75 (45 minutes) ............................. 1.5 hours .......................................... 270 216 600 1 600 0.25 (15 minutes) ............................. 150 10,000 2,400 400 2,400 1 1 1 1 10,000 2,400 400 2,400 0.08 0.25 0.50 0.17 (5 minutes) ............................... (15 minutes) ............................. (30 minutes) ............................. (10 minutes) ............................. 800 600 200 408 Total (General Public) ................ 16,304 ........................ ........................ ........................................................... 2,644 Physician Focus Group Interviews ... 144 1 144 1.5 hours .......................................... 216 Total (Physician) ........................ 144 ........................ ........................ ........................................................... 216 Total (Overall) ..................... 16,448 ........................ ........................ ........................................................... 2,860 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Brief interviews with callers to test message concepts and strategies following their call-in request to the FDA Center for Tobacco Products 1–800 number. The number of respondents to be included in each new pretest will vary, depending on the nature of the material or message being tested and the target audience. However, for illustrative purposes, table 1 provides examples of the types of studies that may be administered and estimated burden levels that may be incurred during each year of the 3-year period. Time to read, view, or listen to the message being tested is built into the ‘‘Hours per Response’’ figures. Dated: January 17, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–01445 Filed 1–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with [Docket No. FDA–2012–N–0032] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 18:39 Jan 24, 2013 Jkt 229001 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: Fax written comments on the collection of information by February 25, 2013. 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 0910–0659 and title, ‘‘Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.capezzuto@fda.hhs.gov. PO 00000 Frm 00057 Fmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User SUPPLEMENTARY INFORMATION: Sfmt 4703 Fee Amendments of 2008—(OMB Control Number 0910–0659)—Extension Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA II) (Pub. L. 316) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) by, among other things, creating section 512(l)(3) to require that the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The legislation was enacted to address the problem of antimicrobial resistance and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals (154 Congressional Record H7534). Each report must specify: (1) The amount of each antimicrobial active ingredient by container size, strength, E:\FR\FM\25JAN1.SGM 25JAN1 5464 Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The first report under the statute was to be submitted not later than March 31, 2010. The report covered the period of the preceding calendar year and included separate information for each month of the calendar year. We are now seeking to further implement the statutory requirements of ADUFA II and enhance its public health and safety mission as envisioned by Congress by introducing an electronic form for the submission of the required annual reports under ADUFA II. The eform FDA 3744a will enable sponsors to submit electronically and capture all information as mandated by Section 105 of ADUFA II. Form FDA 3744 will continue to be designated for paper submissions. List of information required on form FDA 3744 and e-form FDA 3744a: • Application Type • Application Number • Firm Name • Dosage Form(s) • Production Class(es) • Animal Species—Food Animal or Food and Non-Food Animal • Indications • Active Ingredient(s) • Domestic Quantities Æ Unit of Measure for All Active Ingredients Æ Calendar Year Æ Quantity Sold by Month for All Active Ingredients Æ Annual Total Sold for All Active Ingredients • Export Quantities Æ Unit of Measure for All Active Ingredients Æ Calendar Year Æ Quantity Sold by Month for All Active Ingredients Æ Annual Total Sold for All Active Ingredients • Individual Product Information for All Active Ingredients Æ Dosage Form Æ Container Size Æ Container Units Æ Active Ingredient Strength • Quantities of Individual Products Sold or Distributed (Domestic and Export) Æ Unit of Measure for All Active Ingredients Æ Quantity Sold by Month for All Active Ingredients Æ Annual Total Sold for All Active Ingredients FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Annual Reports for Sponsors With Active Applications—Paper Submission. Annual Reports for Sponsors With Active Applications—Electronic Submission. Annual Reports for Sponsors With Inactive Applications—Paper Submission. Annual Reports for Sponsors With Inactive Applications—Electronic Submission. 3744 ...................... 14 5.9 83 60 4,980 $6,975 e-Form 3744a ....... 12 6.7 80 50 4,000 0 3744 ...................... 13 6.2 81 2 162 0 e-Form 3744a ....... 11 7.3 80 2 160 0 Total ............... ............................... ........................ ........................ ........................ ........................ 9,302 $6,975 Total hours Capital costs are no operating and maintenance costs associated with this collection of information. The total annual responses were calculated by multiplying the number of respondents times the number of responses per respondent. Total burden hours were calculated by multiplying total annual responses times the average burden per response. As explained in the supporting statement for the subject mstockstill on DSK4VPTVN1PROD with Total annual responses Average burden per response Form FDA No. 1 There Number of respondents Number of responses per respondent FD&C Act section 512(1)(3) VerDate Mar<15>2010 18:39 Jan 24, 2013 Jkt 229001 collection of information (OMB control number 0910–0659), the initial one-time capital costs are for the design of the report. Here, e-form FDA 3744a and reporting via the Electronic Submission Gateway are provided by FDA. Thus, the remaining cost, as described in approved OMB control number 0910– PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 0659 is $6,975 per year (3 hours × $46.50 wage rate × 50 sponsors) = $6,975. FDA believes that the sponsors already possess the computer equipment needed to prepare the report so that additional capital expenditures will not be necessary. E:\FR\FM\25JAN1.SGM 25JAN1 5465 Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR 514.80(b)(5) Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Records and reports concerning experience with approved new animal drugs—special drug experience report ..................................................... 34 1 34 2 68 mstockstill on DSK4VPTVN1PROD with 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Total annual records were calculated by multiplying the number of recordkeepers times the number of records per recordkeeper. Total hours were calculated by multiplying total annual records times the average burden per recordkeeping. In the Federal Register of January 17, 2012 (77 FR 2302), FDA published a 60day notice requesting public comment on the proposed collection of information to which three comments were received: two from organizations and one from a member of Congress. The commenters generally supported the collection of sales data, and stated that this information would be useful in assessing antimicrobial drugs used in food-producing animals to better address the problem of antimicrobial resistance. One commenter stated that the information supplied by drug companies should be submitted in a format that would allow it to be easily merged with data from other FDA databases. Beyond the scope of this Federal Register notice, all commenters recommended collection of antimicrobial use information in addition to the current requirements of ADUFA II sales reporting. All commenters also recommended revisions to the public reporting of the data being collected. The commenters requested FDA report sales of antimicrobial drug classes by month, by route of administration, by indication, by over-the-counter or prescription status, or grouped by their importance in human medicine. It was recommended that FDA collect and publicly report distribution information down to the state or regional level. ADUFA II requires that no class with fewer than three distinct sponsors of approved applications shall be independently reported; it was recommended that FDA seek additional authority from Congress to report sales figures for all antimicrobial classes regardless of the number of distinct drug sponsors. There was also a recommendation that all of the information collected be made publicly available in a searchable database. VerDate Mar<15>2010 19:25 Jan 24, 2013 Jkt 229001 FDA has considered the comments, but at this time we can only require the submission of information on the new eform FDA 3744a that is expressly required to be submitted by section 512(l)(3) of the FD&C Act. We are pursuing notice and comment rulemaking to codify these requirements, and are currently assessing any additional data requirements. In this regard, FDA published an Advance Notice of Proposed Rulemaking on July 27, 2012, in which FDA solicited comment on the following: (1) Whether FDA should require submission of an estimate of the amount of antimicrobial ingredient sold or distributed for use in each approved food animal species, (2) how FDA can best compile and present required summary information, and (3) alternative methods there may be for obtaining additional data and information about the extent of antimicrobial drug use in foodproducing animals and are there alternative methods the Agency can employ within its existing authority. Dated: January 17, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–01446 Filed 1–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 27, 2013 between approximately 8:30 a.m. and 2:45 p.m. Location: National Institutes of Health (NIH) Fishers Lane Conference Center, Terrace Level, Rooms 508–510, 5635 Fishers Lane, Rockville, MD, 20852. Please enter the building through the main front entrance on Fishers Lane and take the elevators down to the T-Terrace Level. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at http://videocast.nih.gov. Contact Person: Donald W. Jehn or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1– 800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 27, 2013, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013–2014 influenza season. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 20, 2013. Oral presentations from the public will be scheduled between approximately 12:35 p.m. and 1:35 p.m. Those individuals interested in making E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5463-5465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01446]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0032]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Antimicrobial Animal 
Drug Distribution Reports Under Section 105 of the Animal Drug User Fee 
Amendments of 2008

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 
February 25, 2013.

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 0910-0659 and 
title, ``Antimicrobial Animal Drug Distribution Reports Under Section 
105 of the Animal Drug User Fee Amendments of 2008.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@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. Antimicrobial Animal Drug Distribution Reports 
Under Section 105 of the Animal Drug User

Fee Amendments of 2008--(OMB Control Number 0910-0659)--Extension

    Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 
II) (Pub. L. 316) amended section 512 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) by, among other things, 
creating section 512(l)(3) to require that the sponsor of each new 
animal drug that contains an antimicrobial agent submit an annual 
report to FDA on the amount of each antimicrobial active ingredient in 
the drug that is sold or distributed for use in food-producing animals, 
including information on any distributor-labeled product. The 
legislation was enacted to address the problem of antimicrobial 
resistance and to help ensure that FDA has the necessary information to 
examine safety concerns related to the use of antibiotics in food-
producing animals (154 Congressional Record H7534).
    Each report must specify: (1) The amount of each antimicrobial 
active ingredient by container size, strength,

[[Page 5464]]

and dosage form; (2) quantities distributed domestically and quantities 
exported; and (3) a listing of the target animals, indications, and 
production classes that are specified on the approved label of the 
product. The first report under the statute was to be submitted not 
later than March 31, 2010.
    The report covered the period of the preceding calendar year and 
included separate information for each month of the calendar year.
    We are now seeking to further implement the statutory requirements 
of ADUFA II and enhance its public health and safety mission as 
envisioned by Congress by introducing an electronic form for the 
submission of the required annual reports under ADUFA II. The e-form 
FDA 3744a will enable sponsors to submit electronically and capture all 
information as mandated by Section 105 of ADUFA II. Form FDA 3744 will 
continue to be designated for paper submissions.
    List of information required on form FDA 3744 and e-form FDA 3744a:
     Application Type
     Application Number
     Firm Name
     Dosage Form(s)
     Production Class(es)
     Animal Species--Food Animal or Food and Non-Food Animal
     Indications
     Active Ingredient(s)
     Domestic Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
     Export Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
     Individual Product Information for All Active Ingredients
    [cir] Dosage Form
    [cir] Container Size
    [cir] Container Units
    [cir] Active Ingredient Strength
     Quantities of Individual Products Sold or Distributed 
(Domestic and Export)
    [cir] Unit of Measure for All Active Ingredients
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
    FD&C Act section 512(1)(3)          Form FDA No.         Number of     responses per   Total annual     burden per      Total hours    Capital costs
                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors With    3744................              14             5.9              83              60           4,980          $6,975
 Active Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              12             6.7              80              50           4,000               0
 Active Applications--Electronic
 Submission.
Annual Reports for Sponsors With    3744................              13             6.2              81               2             162               0
 Inactive Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              11             7.3              80               2             160               0
 Inactive Applications--Electronic
 Submission.
                                                         -----------------------------------------------------------------------------------------------
    Total.........................  ....................  ..............  ..............  ..............  ..............           9,302          $6,975
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    The total annual responses were calculated by multiplying the 
number of respondents times the number of responses per respondent. 
Total burden hours were calculated by multiplying total annual 
responses times the average burden per response. As explained in the 
supporting statement for the subject collection of information (OMB 
control number 0910-0659), the initial one-time capital costs are for 
the design of the report. Here, e-form FDA 3744a and reporting via the 
Electronic Submission Gateway are provided by FDA. Thus, the remaining 
cost, as described in approved OMB control number 0910-0659 is $6,975 
per year (3 hours x $46.50 wage rate x 50 sponsors) = $6,975. FDA 
believes that the sponsors already possess the computer equipment 
needed to prepare the report so that additional capital expenditures 
will not be necessary.

[[Page 5465]]



                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of       Number of records     Total annual     Average burden per
                 21 CFR 514.80(b)(5)                     recordkeepers     per recordkeeper         records          recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records and reports concerning experience with                       34                   1                  34                   2                  68
 approved new animal drugs--special drug experience
 report.............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Total annual records were calculated by multiplying the number of 
recordkeepers times the number of records per recordkeeper. Total hours 
were calculated by multiplying total annual records times the average 
burden per recordkeeping.
    In the Federal Register of January 17, 2012 (77 FR 2302), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information to which three comments were received: two 
from organizations and one from a member of Congress. The commenters 
generally supported the collection of sales data, and stated that this 
information would be useful in assessing antimicrobial drugs used in 
food-producing animals to better address the problem of antimicrobial 
resistance. One commenter stated that the information supplied by drug 
companies should be submitted in a format that would allow it to be 
easily merged with data from other FDA databases.
    Beyond the scope of this Federal Register notice, all commenters 
recommended collection of antimicrobial use information in addition to 
the current requirements of ADUFA II sales reporting. All commenters 
also recommended revisions to the public reporting of the data being 
collected. The commenters requested FDA report sales of antimicrobial 
drug classes by month, by route of administration, by indication, by 
over-the-counter or prescription status, or grouped by their importance 
in human medicine. It was recommended that FDA collect and publicly 
report distribution information down to the state or regional level. 
ADUFA II requires that no class with fewer than three distinct sponsors 
of approved applications shall be independently reported; it was 
recommended that FDA seek additional authority from Congress to report 
sales figures for all antimicrobial classes regardless of the number of 
distinct drug sponsors. There was also a recommendation that all of the 
information collected be made publicly available in a searchable 
database.
    FDA has considered the comments, but at this time we can only 
require the submission of information on the new e-form FDA 3744a that 
is expressly required to be submitted by section 512(l)(3) of the FD&C 
Act. We are pursuing notice and comment rulemaking to codify these 
requirements, and are currently assessing any additional data 
requirements. In this regard, FDA published an Advance Notice of 
Proposed Rulemaking on July 27, 2012, in which FDA solicited comment on 
the following: (1) Whether FDA should require submission of an estimate 
of the amount of antimicrobial ingredient sold or distributed for use 
in each approved food animal species, (2) how FDA can best compile and 
present required summary information, and (3) alternative methods there 
may be for obtaining additional data and information about the extent 
of antimicrobial drug use in food-producing animals and are there 
alternative methods the Agency can employ within its existing 
authority.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01446 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P