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Federal Register / Vol. 73, No.

68 / Tuesday, April 8, 2008 / Notices 19073

ANNUAL BURDEN ESTIMATES


Number of Average
Number of Total annual
Instrument responses per burden hours
respondents burden hours
respondent per response

Semi-Structured Discussion and Information-Gathering Protocol ................... 600 1 .5 300

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 300

In compliance with the requirements ACTION: Notice. existing collection of information,


of Section 3506(c)(2)(A) of the before submitting the collection to OMB
Paperwork Reduction Act of 1995, the SUMMARY: The Food and Drug for approval. To comply with this
Administration for Children and Administration (FDA) is announcing an requirement, FDA is publishing notice
Families is soliciting public comment opportunity for public comment on the of the proposed collection of
on the specific aspects of the proposed collection of certain information set forth in this document.
information collection described above. information by the agency. Under the With respect to the following
Copies of the proposed collection of Paperwork Reduction Act of 1995 (the collection of information, FDA invites
information can be obtained and PRA), Federal agencies are required to comments on these topics: (1) Whether
comments may be forwarded by writing publish notice in the Federal Register the proposed collection of information
to the Administration for Children and concerning each proposed collection of is necessary for the proper performance
Families, Office Planning, Research and information, including each proposed of FDA’s functions, including whether
Evaluation, 370 L’Enfant Promenade, extension of an existing collection of the information will have practical
SW., Washington, DC 20447, Attn: ACF information, and to allow 60 days for utility; (2) the accuracy of FDA’s
public comment in response to the
Reports Clearance Officer. E-mail estimate of the burden of the proposed
notice. This notice solicits comments on
address: collection of information, including the
the reporting and recordkeeping
OPREinfocollection@acf.hhs.gov. All validity of the methodology and
requirements for ‘‘New Animal Drugs
requests should be identified by the title assumptions used; (3) ways to enhance
for Investigational Use.’’
of the information collection. the quality, utility, and clarity of the
The Department specifically requests DATES: Submit written or electronic
information to be collected; and (4)
comments on (a) Whether the proposed comments on the collection of ways to minimize the burden of the
collection of information is necessary information by June 9, 2008. collection of information on
for the proper performance of the ADDRESSES: Submit electronic respondents, including through the use
functions of the agency, including comments on the collection of of automated collection techniques,
whether the information shall have information to: http:// when appropriate, and other forms of
practical utility; (b) the accuracy of the www.regulations.gov. Submit written information technology.
agency’s estimate of the burden of the comments on the collection of
proposed collection of information; (c) information to the Division of Dockets New Animal Drugs for Investigational
the quality, utility, and clarity of the Management (HFA–305), Food and Drug Use—21 CFR Part 511 (OMB Control
information to be collected; and (d) Administration, 5630 Fishers Lane, rm. Number 0910–0117)—Extension
ways to minimize the burden of the 1061, Rockville, MD 20852. All FDA has authority under the Federal
collection of information on comments should be identified with the Food, Drug, and Cosmetic Act (the act)
respondents, including through the use docket number found in brackets in the to approve new animal drugs. Section
of automated collection techniques or heading of this document. 512(j) of the act (21 U.S.C 360b(j)),
other forms of information technology. FOR FURTHER INFORMATION CONTACT: authorized FDA to issue regulations for
Consideration will be given to Denver Presley, Jr., Office of the Chief the investigational use of new animal
comments and suggestions submitted Information Officer (HFA–250), Food drugs. The regulations which set forth
within 60 days of this publication. and Drug Administration, 5600 Fishers conditions for investigational use of
Lane, Rockville, MD 20857, 301–827– new animal drugs are codified under
Dated: March 31, 2008.
1472. part 511 (21 CFR part 511). If a new
Brendan C. Kelly,
SUPPLEMENTARY INFORMATION: Under the animal drug is only for tests in vitro, or
OPRE Reports Clearance Officer.
PRA (44 U.S.C. 3501–3520), Federal testing in laboratory research animals,
[FR Doc. E8–7139 Filed 4–7–08; 8:45 am]
agencies must obtain approval from the the person distributing the new animal
BILLING CODE 4184–01–M
Office of Management and Budget drug must maintain records showing: (1)
(OMB) for each collection of The name and post office address of the
information they conduct or sponsor. expert or expert organization to whom
DEPARTMENT OF HEALTH AND
‘‘Collection of information’’ is defined the drug is shipped; and (2) the date,
HUMAN SERVICES
in 44 U.S.C. 3502(3) and 5 CFR quantity, batch or code mark for each
Food and Drug Administration 1320.3(c) and includes agency requests shipment for a period of 2 years after
or requirements that members of the such shipment or delivery. Prior to
[Docket No. FDA–2008–N–0172] public submit reports, keep records, or shipping a new animal drug for clinical
provide information to a third party. investigations in animals, a sponsor
Agency Information Collection
Section 3506(c)(2)(A) of the PRA (44 must submit to FDA a Notice of Claimed
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Activities; Proposed Collection;


U.S.C. 3506(c)(2)(A)) requires Federal Investigational Exemption (NCIE). The
Comment Request; New Animal Drugs
agencies to provide a 60-day notice in NCIE must contain, among other things,
for Investigational Use
the Federal Register concerning each the following specific information: (1)
AGENCY: Food and Drug Administration, proposed collection of information, The identity of the new animal drug; (2)
HHS. including each proposed extension of an labeling; (3) a statement of compliance

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19074 Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices

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

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Respondents per Response Responses Response

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 BURDEN1


Annual Frequency
No. of Total Annual Hours per
21 CFR Section per Total Hours
Recordkeepers Records Record
Recordkeeping

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 Please note that on January 15, 2008, DEPARTMENT OF HEALTH AND
requirements, record preparation, and the FDA Division of Dockets HUMAN SERVICES
maintenance for this collection of Management Web site transitioned to
information are based on agency the Federal Dockets Management Food and Drug Administration
communication with industry and System (FDMS). FDMS is a [Docket No. FDA–2008–D–0199] (formerly
agency records. Based on the number of Government-wide, electronic docket Docket No. 2006D–0526)
sponsors subject to animal drug user management system. Electronic
fees, FDA estimates there are 134 comments or submissions will be International Conference on
respondents. This estimate is used accepted by FDA through FDMS only. Harmonisation; Guidance on E15
consistently throughout the burden Pharmacogenomics Definitions and
Dated: March 31, 2008. Sample Coding; Availability
tables and for example, the ‘‘annual
Jeffrey Shuren,
frequency per respondent’’ was AGENCY: Food and Drug Administration,
Associate Commissioner for Policy and
calculated by dividing the total annual HHS.
Planning.
responses by the number of ACTION: Notice.
[FR Doc. E8–7255 Filed 4–7–08; 8:45 am]
respondents. Additional information
needed to make final calculations for BILLING CODE 4160–01–S SUMMARY: The Food and Drug
the total burden estimates in tables 1 Administration (FDA) is announcing the
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and 2 of this document, i.e., the hours availability of a guidance entitled ‘‘E15
per response, the hours per record, the Definitions for Genomic Biomarkers,
number of NCIEs received, etc., was Pharmacogenomics, Pharmacogenetics,
derived from agency records. Genomic Data and Sample Coding
Categories.’’ The guidance was prepared

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