[Federal Register: October 27, 2003 (Volume 68, Number 207)]
[Page 61220-61221]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0057]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Final Guidance for 
Industry: How to Use E-Mail to Submit a Protocol

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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 
November 26, 2003.

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, or e-mail: Fumie_Yokota@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, Rockville, MD 20857, 301-827-1472.

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:

How to Use E-Mail to Submit a Protocol

    The Center for Veterinary Medicine (CVM) may review protocols for 
safety and effectiveness studies of new animal drugs submitted by 
sponsors. The review of protocols facilitates the drug review and 
approval processes.
    Protocols for nonclinical laboratory studies (safety studies) are 
required under 21 CFR 58.120. Protocols for effectiveness studies are 
required under 21 CFR 514.117(b). The burden hours associated with 
preparing the protocols and appendices were reported and approved under 
OMB control number 0910-0119 for nonclinical laboratory studies and OMB 
control number 0910-0346 for adequate and well-controlled effectiveness 
studies. In this guidance document, CVM is giving sponsors the option 
to submit a protocol as an attachment via the Internet.
    In the Federal Register of April 4, 2003 (68 FR 16522), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received in response to that 
    FDA estimates the burden for this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                  Annual Frequency per      Total Annual
               Form FDA No.                  No. of Respondents         Response          [chyph]Responses     Hours per Response        Total Hours
3,536                                              190                     0.52                100                     0.20                 20
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 61221]]

    The burden estimate was calculated as the time it takes to 
``submit'' the protocol which consists of filling out the form and 
pressing the ``insert submission'' button, adding the password and 
pressing the ``mail to'' button, since the burden for protocol is 
already estimated under OMB control number 0910-0119 for nonclinical 
laboratory studies and OMB control number 0910-0346 for efficacy 
studies. The number of approved sponsors is 190, we routinely receive 
about 100 protocols a year, and the 12 minutes (.2 *60 minutes/hour) is 
an estimate based on talking to participating sponsors and our testing 
the use of the form.

    Dated: October 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26963 Filed 10-24-03; 8:45 am]