[Federal Register: August 11, 2004 (Volume 69, Number 154)]
[Page 48876-48877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0497]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry on Pharmacogenomic Data Submissions

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

[[Page 48877]]

(OMB) for review and clearance under the Paperwork Reduction Act of 

DATES: Fax written comments on the collection of information by 
September 10, 2004.

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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.

Draft Guidance for Industry on Pharmacogenomic Data Submissions (OMB 
Control Numbers 0910-0014, 0910-0001, and 0910-0338)--Extension

    The guidance provides recommendations to sponsors submitting or 
holding investigational new drugs (INDs), new drug applications (NDAs), 
or biologic liscensing 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 in parts 312, 314, and 601 (21 CFR 312, 
314, and 601) 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 and are approved by OMB under control 
numbers 0910-0014 (part 312--INDs; approved until January 1, 2006); 
0910-0001 (part 314--NDAs and annual reports; approved until March 31, 
2005); and 0910-0338 (approved until August 31, 2005).
    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 familiarity with sponsors' interest in submitting pharmacogenomic 
data during the drug development process, FDA estimates that 
approximately 20 sponsors will submit approximately 80 VGDSs and that, 
on average, each VGDS will take approximately 10 hours to prepare and 
submit to FDA.
    In the Federal Register of November 4, 2003 (68 FR 62461), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received on the information 
collection estimates.

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                          Number of
                       Number of        Responses per       Total Annual        Hours per         Total Hours
                      Respondents         Respondent         Responses           Response
Voluntary genomic                 20                  4                 80                 10                800
 data submissions
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    Dated: August 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18360 Filed 8-6-04; 12:04 pm]