Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension, 70330-70331 [E7-23996]

Download as PDF 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 70331 Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices 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. Guidance for Industry on Pharmacogenomic Data Submissions (OMB Control Number 0910–0557)— Extension The guidance provides recommendations to sponsors submitting or holding investigational new drugs (INDs), new drug applications (NDAs), or biologic licensing applications (BLAs) on what pharmacogenomic data should be submitted to the agency during the drug development process. Sponsors holding and applicants submitting INDs, NDAs, or BLAs are subject to FDA requirements for submitting to the agency data relevant to drug safety and efficacy (§§ 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12). Description of Respondents: Sponsors submitting or holding INDs, NDAs, or BLAs for human drugs and biologics. Burden Estimate: The guidance interprets FDA regulations for IND, NDA, or BLA submissions, clarifying when the regulations require pharmacogenomics data to be submitted and when the submission of such data is voluntary. The pharmacogenomic data submissions described in the guidance that are required to be submitted to an IND, NDA, BLA, or annual report are covered by the information collection requirements under parts 312, 314, and 601 (21 CFR parts 312, 314, and 601) and are approved by OMB under control numbers 0910–0014 (part 312—INDs); 0910–0001 (part 314—NDAs and annual reports); and 0910–0338 (part 601— BLAs). The guidance distinguishes between pharmacogenomic tests that may be considered valid biomarkers appropriate for regulatory decisionmaking, and other, less well developed exploratory tests. The submission of exploratory pharmacogenomic data is not required under the regulations, although the agency encourages the voluntary submission of such data. The guidance describes the voluntary genomic data submission (VGDS) that can be used for such a voluntary submission. The guidance does not recommend a specific format for the VGDS, except that such a voluntary submission be designated as a VGDS. The data submitted in a VGDS and the level of detail should be sufficient for FDA to be able to interpret the information and independently analyze the data, verify results, and explore possible genotype-phenotype correlations across studies. FDA does not want the VGDS to be overly burdensome and time-consuming for the sponsor. FDA has estimated the burden of preparing a voluntary submission described in the guidance that should be designated as a VGDS. Based on FDA’s experience with this guidance over the past few years, and on FDA’s familiarity with sponsors’ interest in submitting pharmacogenomic data during the drug development process, FDA estimates that approximately 8 sponsors will submit approximately 10 VGDSs and that, on average, each VGDS will take approximately 50 hours to prepare and submit to FDA. In the Federal Register of August 21, 2007 (72 FR 46636), FDA published a 60-day notice requesting public comment on the information collection provisions. We received one comment which requested clarification of how the confidential information received in a VGDS will remain outside the public domain and not end up being cited in a publicly posted submission review. FDA Response: Information received as part of a VGDS not to be used for regulatory decisionmaking and received in confidence is covered by the same confidentiality levels of INDs, NDAs, and BLAs. There is no publicly posted submission review associated with the data in a VGDS, and release of information associated with a VGDS is exclusively up to the sponsor of the VGDS and not to FDA. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Number of Respondents Voluntary Genomic Data Submissions 1 There Number of Responses per Respondent 8 1.25 Hours per Response 10 Total Hours 50 500 are no capital costs or operating and maintenance costs associated with this collection. Dated: December 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–23996 Filed 12–10–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S pwalker on PROD1PC71 with NOTICES Total Annual Responses [Docket No. 2007N–0236] Food and Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 PO 00000 Notice. Frm 00043 Fmt 4703 Sfmt 4703 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. Fax written comments on the collection of information by January 10, 2008. 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: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments ADDRESSES: E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70330-70331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23996]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0317]


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 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 0910-0557. Also

[[Page 70331]]

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.

Guidance for Industry on Pharmacogenomic Data Submissions (OMB Control 
Number 0910-0557)--Extension

    The guidance provides recommendations to sponsors submitting or 
holding investigational new drugs (INDs), new drug applications (NDAs), 
or biologic licensing applications (BLAs) on what pharmacogenomic data 
should be submitted to the agency during the drug development process. 
Sponsors holding and applicants submitting INDs, NDAs, or BLAs are 
subject to FDA requirements for submitting to the agency data relevant 
to drug safety and efficacy (Sec. Sec.  312.22, 312.23, 312.31, 312.33, 
314.50, 314.81, 601.2, and 601.12).
    Description of Respondents: Sponsors submitting or holding INDs, 
NDAs, or BLAs for human drugs and biologics.
    Burden Estimate: The guidance interprets FDA regulations for IND, 
NDA, or BLA submissions, clarifying when the regulations require 
pharmacogenomics data to be submitted and when the submission of such 
data is voluntary. The pharmacogenomic data submissions described in 
the guidance that are required to be submitted to an IND, NDA, BLA, or 
annual report are covered by the information collection requirements 
under parts 312, 314, and 601 (21 CFR parts 312, 314, and 601) and are 
approved by OMB under control numbers 0910-0014 (part 312--INDs); 0910-
0001 (part 314--NDAs and annual reports); and 0910-0338 (part 601--
BLAs).
    The guidance distinguishes between pharmacogenomic tests that may 
be considered valid biomarkers appropriate for regulatory 
decisionmaking, and other, less well developed exploratory tests. The 
submission of exploratory pharmacogenomic data is not required under 
the regulations, although the agency encourages the voluntary 
submission of such data.
    The guidance describes the voluntary genomic data submission (VGDS) 
that can be used for such a voluntary submission. The guidance does not 
recommend a specific format for the VGDS, except that such a voluntary 
submission be designated as a VGDS. The data submitted in a VGDS and 
the level of detail should be sufficient for FDA to be able to 
interpret the information and independently analyze the data, verify 
results, and explore possible genotype-phenotype correlations across 
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
    FDA has estimated the burden of preparing a voluntary submission 
described in the guidance that should be designated as a VGDS. Based on 
FDA's experience with this guidance over the past few years, and on 
FDA's familiarity with sponsors' interest in submitting pharmacogenomic 
data during the drug development process, FDA estimates that 
approximately 8 sponsors will submit approximately 10 VGDSs and that, 
on average, each VGDS will take approximately 50 hours to prepare and 
submit to FDA.
    In the Federal Register of August 21, 2007 (72 FR 46636), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received one comment which requested 
clarification of how the confidential information received in a VGDS 
will remain outside the public domain and not end up being cited in a 
publicly posted submission review.
    FDA Response: Information received as part of a VGDS not to be used 
for regulatory decisionmaking and received in confidence is covered by 
the same confidentiality levels of INDs, NDAs, and BLAs. There is no 
publicly posted submission review associated with the data in a VGDS, 
and release of information associated with a VGDS is exclusively up to 
the sponsor of the VGDS and not to FDA.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                          Number of       Number of Responses     Total Annual       Hours per
                         Respondents        per Respondent         Responses         Response       Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary Genomic                     8                  1.25                 10              50             500
 Data Submissions
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23996 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S
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