Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 70329-70330 [E7-23977]

Download as PDF Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices making processes developed from expert knowledge and experience. In this study, the decision models of certain health care providers concerning treatment options for pregnant and nursing women will be compared to a decision model concerning such treatment options that was derived from the knowledge and experience of FDA reviewers responsible for product labeling. FDA will use telephone interviews to determine from the health care providers the factors that influence their treatment decisions for pregnant and nursing women with chronic conditions. A comparison between expert and health care provider models based on the collected information may identify consequential knowledge gaps that can be redressed through messages or information campaigns designed by FDA. Using a protocol derived from the research that resulted in the ‘‘expert model,’’ trained interviewers will conduct one-on-one telephone discussions with about 25 members of 2 categories of health care providers (described below) who provide health care services to pregnant or nursing women. 70329 The two categories of health care providers are: (1) Those who directly care for pregnant and nursing women, including obstetricians, OB/GYNs (obstetrician/ gynecologists), nurse midwives, and general practitioners. (2) Those who directly care for women of reproductive age with significant chronic health conditions (e.g., allergists, psychiatrists, or cardiologists). FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response 54 Total Annual Responses 1 Hours per Response 1 1.0 TOTAL are no capital costs or operating and maintenance costs associated with this collection of information. The study will involve about 54 respondents and take approximately 1 hour each to complete. These estimates are based on the contractor’s extensive experience with mental models research. FDA conducted pretests of the mental models protocol with three health care providers. These resulted in the current protocol. Dated: December 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–23976 Filed 12–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4816. [Docket No. 2007N–0337] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees AGENCY: Food and Drug Administration, HHS. 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. VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 Fax written comments on the collection of information by January 10, 2008. 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: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0053. Also include the FDA docket number found in brackets in the heading of this document. DATES: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration pwalker on PROD1PC71 with NOTICES 54.0 54.0 1 There ACTION: Total Hours In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Radioactive Drug Research Committees—(OMB Control Number 0910–0053)—Extension Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. Section 361.1 (21 CFR 361.1) sets forth specific regulations regarding the establishment and composition of Radioactive Drug PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Research Committees and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA approved Radioactive Drug Research Committee (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulation, and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each Radioactive Drug Research Committee shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. Minutes shall be kept and shall include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each Radioactive Drug Research Committee shall submit an annual report to FDA. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the Radioactive Drug Research Committee, using FDA Form 2914, and a summary of each study conducted during the proceeding year, using FDA Form 2915. Under § 361.1(d)(5), each investigator shall obtain the proper consent required E:\FR\FM\11DEN1.SGM 11DEN1 70330 Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant, or on the basis of a pregnancy test be confirmed as not pregnant. Under § 361.1(d)(8), the investigator shall immediately report to the Radioactive Drug Research Committee all adverse effects associated with use of the drug, and the committee shall then report to FDA all adverse reactions probably attributed to the use of the radioactive drug. Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)). Types of research studies not permitted under this regulation are also specified, and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an investigational new drug application (IND) under 21 CFR part 312, and the associated information collections are covered in OMB control number 0910– 0014. The primary purpose of this collection of information is to determine if the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson(s) of each individual Radioactive Drug Research Committee, investigators, and participants in the studies. The burden estimates are based on FDA’s experience with these reporting and recordkeeping requirements over the past few years and the number of submissions received by FDA under the regulations. In the Federal Register of September 21, 2007 (72 FR 54044), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents Forms Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 361.1(c)(3) and (c)(4) FDA 2914 80 1 80 1 80 361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190 50 6.8 340 0.1 34 361.1(d)(8) Total Reporting 1 There 1,304 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 Hours per Record Total Hours 361.1(c)(2) 80 4 10 800 361.1(d)(5) 50 6.8 .75 38 Total Recordkeeping 1 There 838 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–23977 Filed 12–10–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S [Docket No. 2007N–0317] Food and Drug Administration 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. Fax written comments on the collection of information by January 10, 2008. DATES: pwalker on PROD1PC71 with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0557. Also ADDRESSES: E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70329-70330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23977]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0337]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Radioactive Drug
Research Committees

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 January
10, 2008.

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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0053. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4816.

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.

Radioactive Drug Research Committees--(OMB Control Number 0910-0053)--
Extension

Under sections 201, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to
issue regulations governing the use of radioactive drugs for basic
scientific research. Section 361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment and composition of Radioactive
Drug Research Committees and their role in approving and monitoring
basic research studies utilizing radiopharmaceuticals. No basic
research study involving any administration of a radioactive drug to
research subjects is permitted without the authorization of an FDA
approved Radioactive Drug Research Committee (Sec. 361.1(d)(7)). The
type of research that may be undertaken with a radiopharmaceutical drug
must be intended to obtain basic information and not to carry out a
clinical trial for safety or efficacy. The types of basic research
permitted are specified in the regulation, and include studies of
metabolism, human physiology, pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each Radioactive Drug Research
Committee shall select a chairman, who shall sign all applications,
minutes, and reports of the committee. Each committee shall meet at
least once each quarter in which research activity has been authorized
or conducted. Minutes shall be kept and shall include the numerical
results of votes on protocols involving use in human subjects. Under
Sec. 361.1(c)(3), each Radioactive Drug Research Committee shall
submit an annual report to FDA. The annual report shall include the
names and qualifications of the members of, and of any consultants used
by, the Radioactive Drug Research Committee, using FDA Form 2914, and a
summary of each study conducted during the proceeding year, using FDA
Form 2915.
Under Sec. 361.1(d)(5), each investigator shall obtain the proper
consent required

[[Page 70330]]

under the regulations. Each female research subject of childbearing
potential must state in writing that she is not pregnant, or on the
basis of a pregnancy test be confirmed as not pregnant.
Under Sec. 361.1(d)(8), the investigator shall immediately report
to the Radioactive Drug Research Committee all adverse effects
associated with use of the drug, and the committee shall then report to
FDA all adverse reactions probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the reporting burden estimate
because they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
Types of research studies not permitted under this regulation are
also specified, and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application (IND) under 21 CFR
part 312, and the associated information collections are covered in OMB
control number 0910-0014.
The primary purpose of this collection of information is to
determine if the research studies are being conducted in accordance
with required regulations and that human subject safety is assured. If
these studies were not reviewed, human subjects could be subjected to
inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson(s)
of each individual Radioactive Drug Research Committee, investigators,
and participants in the studies.
The burden estimates are based on FDA's experience with these
reporting and recordkeeping requirements over the past few years and
the number of submissions received by FDA under the regulations.
In the Federal Register of September 21, 2007 (72 FR 54044), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Forms Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) and (c)(4) FDA 2914 80 1 80 1 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(d)(8) ................. 50 6.8 340 0.1 34
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Reporting ................. ................. ................. ................. ................. 1,304
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency
21 CFR Section Recordkeepers per Recordkeeping Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
361.1(c)(2) 80 4 10 800
----------------------------------------------------------------------------------------------------------------
361.1(d)(5) 50 6.8 .75 38
----------------------------------------------------------------------------------------------------------------
Total Recordkeeping ................. ................. ................. 838
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23977 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S

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