[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16522-16523]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-81]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
eparbuon@cvm.fda.gov.
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\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency Total Annual Hours Total
Form FDA No. Respondents per [chyph]Responses per Hours
Response Response
----------------------------------------------------------------------------------------------------------------
3536 190 0.52 100 0.20 20
----------------------------------------------------------------------------------------------------------------
\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