[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16522-16523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0057]


Guidance for Industry: How to Use E-mail to Submit a Protocol; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (107) entitled ``How 
to Use E-mail to Submit a Protocol.'' This guidance describes how 
sponsors can use e-mail to submit protocols for studies intended to be 
conducted in support of New Animal Drug Applications (NADAs) to the 
Center for Veterinary Medicine (CVM). Electronic submission is part of 
CVM's ongoing initiative to provide a method for paperless submissions. 
This guidance is intended to implement provisions of the Government 
Paperwork Elimination Act (GPEA).

DATES: General comments on agency guidance documents are welcome at any 
time.
    Submit written or electronic comments on the information collection 
requirements by June 3, 2003.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Comments should be identified 
with the full title of the guidance document and the docket number 
found in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written comments on the collection of information 
requirements to the Dockets Management Branch. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth L. Parbuoni, Center for 
Veterinary Medicine (HFV-16), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-3845, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the electronic records and electronic signatures final 
regulation. This regulation, part 11 (21 CFR part 11), sets forth the 
criteria under which the agency considers electronic records, 
electronic signatures, and handwritten signatures executed to 
electronic records to be trustworthy, reliable, and generally 
equivalent to paper records and handwritten signatures executed on 
paper. Electronic records that meet the requirements of part 11 and are 
identified in public docket 92S-0251 as being the type of submission 
the agency will accept in electronic format may be used in lieu of 
paper records unless paper records are specifically required. CVM has 
identified protocols in this public docket. The public docket is 
accessible on the Internet at http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm.
    Establishing a process for acceptance of the electronic submission 
of protocols for studies conducted by sponsors in support of NADAs is 
part of CVM's ongoing initiative to provide a method for paperless 
submissions. Upon request, CVM reviews protocols for safety and 
effectiveness studies. This protocol review facilitates the animal drug 
review process by improving the likelihood that the study design will 
be relevant to NADA approval.
    Currently, sponsors submit protocols to CVM in paper format. CVM is 
publishing this guidance to give sponsors the option to submit a 
protocol as an e-mail attachment via the Internet. This guidance 
implements provisions of the GPEA. The GPEA requires Federal agencies, 
by October 21, 2003, to provide: (1) For the option of the electronic 
maintenance, submission, or disclosure of information, if practicable, 
as a substitute for paper; and (2) for the use and acceptance of 
electronic signatures, where applicable.
    In order to submit a protocol for an NADA study by e-mail, sponsors 
should first register and follow the general instructions in guidance 
108 entitled ``How to Use E-mail to Submit Information to the 
Center for Veterinary Medicine.''

II. Significance of Guidance

    This level 2 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking about using e-mail to submit a protocol. 
The document does not create or confer any rights for or on

[[Page 16523]]

any person and will not operate to bind FDA or the public. Alternative 
methods may be used as long as they satisfy the requirements of the 
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing a notice 
of the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: How to Use E-mail to Submit a Protocol
    Description: 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 Sec.  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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                     Annual
                                                         No. of    Frequency    Total Annual      Hours    Total
                    Form FDA No.                      Respondents     per     [chyph]Responses     per     Hours
                                                                    Response                    Response
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3536                                                       190        0.52           100          0.20       20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate was calculated as the time it takes to submit 
the protocol which consists of filling out the form and pressing the 
``insertsubmission'' 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.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any written comments, except 
that individuals may submit one hard copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document.
    Written comments concerning the information collection requirements 
must be received by the Dockets Management Branch by June 3, 2003. A 
copy of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

V. Electronic Access

    Electronic comments on the guidance document may be submitted on 
the Internet at http://www.fda.gov/dockets/ecomments. Once on the 
Internet site, select ``03D-0057 How to Use E-mail to Submit a 
Protocol'' and follow the directions. A copy of this document may be 
obtained on the Internet at http://www.fda.gov/cvm.

    Dated: March 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-8166 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S