Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use, 19073-19074 [E8-7255]

Download as PDF 19073 Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total annual burden hours Semi-Structured Discussion and Information-Gathering Protocol ................... 600 1 .5 300 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 300 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 31, 2008. Brendan C. Kelly, OPRE Reports Clearance Officer. [FR Doc. E8–7139 Filed 4–7–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration pwalker on PROD1PC71 with NOTICES [Docket No. FDA–2008–N–0172] Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 16:09 Apr 07, 2008 Jkt 214001 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 the reporting and recordkeeping requirements for ‘‘New Animal Drugs for Investigational Use.’’ DATES: Submit written or electronic comments on the collection of information by June 9, 2008. 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: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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. New Animal Drugs for Investigational Use—21 CFR Part 511 (OMB Control Number 0910–0117)—Extension FDA has authority under the Federal Food, Drug, and Cosmetic Act (the act) to approve new animal drugs. Section 512(j) of the act (21 U.S.C 360b(j)), authorized FDA to issue regulations for the investigational use of new animal drugs. The regulations which set forth conditions for investigational use of new animal drugs are codified under part 511 (21 CFR part 511). If a new animal drug is only for tests in vitro, or testing in laboratory research animals, the person distributing the new animal drug must maintain records showing: (1) The name and post office address of the expert or expert organization to whom the drug is shipped; and (2) the date, quantity, batch or code mark for each shipment for a period of 2 years after such shipment or delivery. Prior to shipping a new animal drug for clinical investigations in animals, a sponsor must submit to FDA a Notice of Claimed Investigational Exemption (NCIE). The NCIE must contain, among other things, the following specific information: (1) The identity of the new animal drug; (2) labeling; (3) a statement of compliance E:\FR\FM\08APN1.SGM 08APN1 19074 Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices of any non-clinical laboratory studies with good laboratory practices; (4) the name and address of each clinical investigator; (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped; and (6) information regarding the use of edible tissues from investigational animals. Part 511 also requires that records be established and maintained to document the distribution and use of the investigational drug to assure that its use is safe and that the distribution is controlled to prevent potential abuse. The agency uses these required records under its Bio-Research Monitoring Program to monitor the validity of the studies submitted to FDA to support new animal drug approval and to assure that proper use of the drug is maintained by the investigator. Investigational new animal drugs are used primarily by the pharmaceutical industry, academic institutions, and the government. Investigators may include individuals from these entities as well as research firms and members of the medical professional. Respondents for this collection of information are investigators who use new animal drugs for investigational purposes. FDA estimates the burden for this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 511.1(b)(4) 134 7.66 1,027 8 8,216 511.1(b)(5) 134 .19 25 140 3,500 511.1(b)(6) 134 .01 2 1 2 511.1(b)(8)(ii) 134 .11 15 20 300 511.1(b)(9) 134 6.7 20 8 160 Total 1 There 12,178 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 511.1(a)(3) 134 2.96 400 9 3,600 511.1(b)(3) 134 7.66 1,027 1 1,027 511.1(b)(7)(ii) 134 7.46 1,000 3.5 3,500 511.1(b)(8)(i) 134 7.46 1,000 3.5 3,500 Total pwalker on PROD1PC71 with NOTICES 1 There 11,627 are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for reporting requirements, record preparation, and maintenance for this collection of information are based on agency communication with industry and agency records. Based on the number of sponsors subject to animal drug user fees, FDA estimates there are 134 respondents. This estimate is used consistently throughout the burden tables and for example, the ‘‘annual frequency per respondent’’ was calculated by dividing the total annual responses by the number of respondents. Additional information needed to make final calculations for the total burden estimates in tables 1 and 2 of this document, i.e., the hours per response, the hours per record, the number of NCIEs received, etc., was derived from agency records. VerDate Aug<31>2005 16:09 Apr 07, 2008 Jkt 214001 Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. Dated: March 31, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7255 Filed 4–7–08; 8:45 am] Frm 00028 Fmt 4703 Food and Drug Administration [Docket No. FDA–2008–D–0199] (formerly Docket No. 2006D–0526) International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.’’ The guidance was prepared BILLING CODE 4160–01–S PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 73, Number 68 (Tuesday, April 8, 2008)]
[Notices]
[Pages 19073-19074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7255]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0172]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drugs for Investigational Use

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 the reporting and 
recordkeeping requirements for ``New Animal Drugs for Investigational 
Use.''

DATES: Submit written or electronic comments on the collection of 
information by June 9, 2008.

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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

New Animal Drugs for Investigational Use--21 CFR Part 511 (OMB Control 
Number 0910-0117)--Extension

    FDA has authority under the Federal Food, Drug, and Cosmetic Act 
(the act) to approve new animal drugs. Section 512(j) of the act (21 
U.S.C 360b(j)), authorized FDA to issue regulations for the 
investigational use of new animal drugs. The regulations which set 
forth conditions for investigational use of new animal drugs are 
codified under part 511 (21 CFR part 511). If a new animal drug is only 
for tests in vitro, or testing in laboratory research animals, the 
person distributing the new animal drug must maintain records showing: 
(1) The name and post office address of the expert or expert 
organization to whom the drug is shipped; and (2) the date, quantity, 
batch or code mark for each shipment for a period of 2 years after such 
shipment or delivery. Prior to shipping a new animal drug for clinical 
investigations in animals, a sponsor must submit to FDA a Notice of 
Claimed Investigational Exemption (NCIE). The NCIE must contain, among 
other things, the following specific information: (1) The identity of 
the new animal drug; (2) labeling; (3) a statement of compliance

[[Page 19074]]

of any non-clinical laboratory studies with good laboratory practices; 
(4) the name and address of each clinical investigator; (5) the 
approximate number of animals to be treated or amount of new animal 
drug(s) to be shipped; and (6) information regarding the use of edible 
tissues from investigational animals. Part 511 also requires that 
records be established and maintained to document the distribution and 
use of the investigational drug to assure that its use is safe and that 
the distribution is controlled to prevent potential abuse. The agency 
uses these required records under its Bio-Research Monitoring Program 
to monitor the validity of the studies submitted to FDA to support new 
animal drug approval and to assure that proper use of the drug is 
maintained by the investigator.
    Investigational new animal drugs are used primarily by the 
pharmaceutical industry, academic institutions, and the government. 
Investigators may include individuals from these entities as well as 
research firms and members of the medical professional. Respondents for 
this collection of information are investigators who use new animal 
drugs for investigational purposes.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(4)                      134               7.66              1,027                  8              8,216
----------------------------------------------------------------------------------------------------------------
511.1(b)(5)                      134                .19                 25                140              3,500
----------------------------------------------------------------------------------------------------------------
511.1(b)(6)                      134                .01                  2                  1                  2
----------------------------------------------------------------------------------------------------------------
511.1(b)(8)(ii)                  134                .11                 15                 20                300
----------------------------------------------------------------------------------------------------------------
511.1(b)(9)                      134                6.7                 20                  8                160
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................             12,178
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
511.1(a)(3)                      134               2.96                400                  9              3,600
----------------------------------------------------------------------------------------------------------------
511.1(b)(3)                      134               7.66              1,027                  1              1,027
----------------------------------------------------------------------------------------------------------------
511.1(b)(7)(ii)                  134               7.46              1,000                3.5              3,500
----------------------------------------------------------------------------------------------------------------
511.1(b)(8)(i)                   134               7.46              1,000                3.5              3,500
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................             11,627
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for reporting requirements, record 
preparation, and maintenance for this collection of information are 
based on agency communication with industry and agency records. Based 
on the number of sponsors subject to animal drug user fees, FDA 
estimates there are 134 respondents. This estimate is used consistently 
throughout the burden tables and for example, the ``annual frequency 
per respondent'' was calculated by dividing the total annual responses 
by the number of respondents. Additional information needed to make 
final calculations for the total burden estimates in tables 1 and 2 of 
this document, i.e., the hours per response, the hours per record, the 
number of NCIEs received, etc., was derived from agency records.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: March 31, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7255 Filed 4-7-08; 8:45 am]
BILLING CODE 4160-01-S
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