Agency Information Collection Activities; Proposed Collection; Comment Request; Antiparasitic Drug and Resistance Survey, 71603-71604 [2012-29094]

Download as PDF 71603 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity/21 CFR Section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Original—812.140 ................................................................ Supplemental—812.140 ....................................................... Nonsignificant—812.140 ...................................................... 356 356 356 1 12 1 356 4,272 356 10 1 6 3,560 4,272 2,136 Total .............................................................................. ........................ ........................ ........................ ........................ 9,968 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity/21 CFR Section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Reports for Nonsignificant Risk Studies—812.150 ............. 1 1 1 6 6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 27, 2012. Leslie Kux, Assistant Commissioner for Policy. 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: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 410B, Rockville, MD 20850, 301–796– 3784, JonnaLynn.capezzuto@fda.hhs.gov. [FR Doc. 2012–29095 Filed 11–30–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0307] Agency Information Collection Activities; Proposed Collection; Comment Request; Antiparasitic Drug and Resistance Survey AGENCY: 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA’s ‘‘Antiparasitic Drug and Resistance Survey.’’ DATES: Submit either electronic or written comments on the collection of information by February 1, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:30 Nov 30, 2012 Jkt 229001 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 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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. Antiparasitic Drug and Resistance Survey—21 CFR Part 514.4 (OMB Control Number 0910–NEW) Resistance of parasites to one or more of the major classes of FDA approved antiparasitic drugs is a documented problem in cattle, horses, sheep, and goats in the United States. The results from this survey will provide FDA information that can be used to make decisions about future approaches to antiparasitic drugs. FDA will make the results of the survey publicly available. FDA plans to survey members of veterinary professional organizations using an Internet-based survey instrument. The questions in the survey are designed to elicit professional opinions regarding the use of antiparasitic drugs and the awareness of antiparasitic drug resistance. The survey will query subjects on topics including: (1) Awareness of the issues related to antiparasitic resistance, (2) methods currently being used to detect and/or monitor for antiparasitic resistance, (3) management practices being used or recommended to manage or reduce antiparasitic resistance, and (4) labeling and marketing considerations for antiparasitic drugs. FDA published a 60-day notice in the Federal Register on July 13, 2010 (75 FR 39948), requesting public comment on the proposed survey, and published a 30-day notice on May 23, 2011 (76 FR E:\FR\FM\03DEN1.SGM 03DEN1 71604 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices 29762), and submitted the Information Collection Request (ICR) package to OMB. FDA subsequently entered into study design and development discussions with OMB officials. OMB decided that FDA should resubmit the Antiparasitic Drug Use and Resistance in Ruminants and Equines Public Meeting (77 FR 7588, February 13, 2012; Docket No. FDA–2012–N–0102). FDA estimates the burden of this collection of information as follows: study with a new 60-day notice and begin a new ICR package. This document responds to that request. Substantial revisions to the scope and content of the survey were also made based on information presented at the TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Portion of study Average burden per response Total annual responses Total hours Pre-test ............................................................................... Survey ................................................................................ 5 650 1 1 5 650 .5 .5 2.5 325 Total ............................................................................ ........................ ........................ ........................ ........................ 327.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA will conduct a pre-test of the survey with five respondents, and it is estimated that it will take 30 minutes (0.5 hour) to complete the pretest, for a total of 2.5 hours. We estimate that 650 respondents will complete the survey. It is estimated that it will take a respondent 30 minutes (0.5 hour) for a total of 325 hours. Thus, the total estimated annual reporting burden is 327.5 hours. FDA’s burden estimate is based on prior experience with consumer surveys that are similar. Dated: November 28, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–29094 Filed 11–30–12; 8:45 am] BILLING CODE 4160–01–P Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Joseph D Mosca, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 435– 2344, moscajos@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) National Institutes of Health [FR Doc. 2012–29092 Filed 11–30–12; 8:45 am] Center for Scientific Review; Notice of Closed Meeting emcdonald on DSK67QTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 27, 2012. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Nanotechnology and Tissue Engineering. Date: December 5, 2012. Time: 11:00 a.m. to 3:00 p.m. VerDate Mar<15>2010 14:30 Nov 30, 2012 Jkt 229001 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special Emphasis Panel. Date: January 11, 2013. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Stanford University School of Medicine, Li Ka Shing Building, 3rd floor, 291 Campus Drive, Rm. LK3C02, Stanford, CA 94305. Contact Person: Ken D. Nakamura, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, 301–402–0838, nakamurk@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: November 27, 2012. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–29091 Filed 11–30–12; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Human Genome Research Institute; Notice of Closed Meeting National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which National Institute on Aging; Notice of Closed Meeting PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Notices]
[Pages 71603-71604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29094]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0307]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Antiparasitic Drug and Resistance Survey

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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on FDA's ``Antiparasitic Drug and Resistance
Survey.''

DATES: Submit either electronic or written comments on the collection
of information by February 1, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to https://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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-410B,
Rockville, MD 20850, 301-796-3784, JonnaLynn.capezzuto@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 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.

Antiparasitic Drug and Resistance Survey--21 CFR Part 514.4 (OMB
Control Number 0910-NEW)

Resistance of parasites to one or more of the major classes of FDA
approved antiparasitic drugs is a documented problem in cattle, horses,
sheep, and goats in the United States. The results from this survey
will provide FDA information that can be used to make decisions about
future approaches to antiparasitic drugs. FDA will make the results of
the survey publicly available.
FDA plans to survey members of veterinary professional
organizations using an Internet-based survey instrument. The questions
in the survey are designed to elicit professional opinions regarding
the use of antiparasitic drugs and the awareness of antiparasitic drug
resistance. The survey will query subjects on topics including: (1)
Awareness of the issues related to antiparasitic resistance, (2)
methods currently being used to detect and/or monitor for antiparasitic
resistance, (3) management practices being used or recommended to
manage or reduce antiparasitic resistance, and (4) labeling and
marketing considerations for antiparasitic drugs.
FDA published a 60-day notice in the Federal Register on July 13,
2010 (75 FR 39948), requesting public comment on the proposed survey,
and published a 30-day notice on May 23, 2011 (76 FR

[[Page 71604]]

29762), and submitted the Information Collection Request (ICR) package
to OMB. FDA subsequently entered into study design and development
discussions with OMB officials. OMB decided that FDA should resubmit
the study with a new 60-day notice and begin a new ICR package. This
document responds to that request. Substantial revisions to the scope
and content of the survey were also made based on information presented
at the Antiparasitic Drug Use and Resistance in Ruminants and Equines
Public Meeting (77 FR 7588, February 13, 2012; Docket No. FDA-2012-N-
0102).
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pre-test....................... 5 1 5 .5 2.5
Survey......................... 650 1 650 .5 325
--------------------------------------------------------------------------------
Total...................... .............. .............. .............. .............. 327.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

FDA will conduct a pre-test of the survey with five respondents,
and it is estimated that it will take 30 minutes (0.5 hour) to complete
the pretest, for a total of 2.5 hours. We estimate that 650 respondents
will complete the survey. It is estimated that it will take a
respondent 30 minutes (0.5 hour) for a total of 325 hours. Thus, the
total estimated annual reporting burden is 327.5 hours. FDA's burden
estimate is based on prior experience with consumer surveys that are
similar.

Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29094 Filed 11-30-12; 8:45 am]
BILLING CODE 4160-01-P

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