[Federal Register: January 8, 2004 (Volume 69, Number 5)]
[Page 1300-1301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2000D-1314]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on How to Use E-Mail to Submit a Notice of Intent to Slaughter for 
Human Food Purposes

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 
February 9, 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
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.

Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent 
to Slaughter for Human Food Purposes--(OMB Control Number 0910-0450)--

    Section 512(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(j)) gives FDA the authority to issue regulations setting 
out the conditions for marketing animals treated with investigational 
new animal drugs for food use. Under this authority, FDA's regulations 
at Sec.  511.1(b)(4) (21 CFR 511.1(b)(4)), provide that sponsors must 
obtain authorization to slaughter these animals for food. The Center 
for Veterinary Medicine (CVM) may grant such authorization to a sponsor 
under Sec.  511.1(b)(5). If CVM authorizes the slaughter of 
investigational animals for food use, CVM issues a slaughter 
authorization letter to new animal drug sponsors which sets the terms 
under which such animals treated with investigational new animal drugs 
may be slaughtered. The authorization letter states that sponsors must 
submit slaughter notices each time such animals are to be slaughtered 
unless CVM waives this notice in the authorization letter. Currently, 
slaughter notices are submitted to CVM on paper. This guidance will 
give sponsors the option to submit a slaughter notice electronically as 
an e-mail attachment. The electronic submission of slaughter notices is 
part of CVM's ongoing initiative to provide a method for paperless 
submissions. The likely respondents to this collection of information 
are new animal drug sponsors who have conducted clinical studies under 
Sec.  511.1(b).
    In the Federal Register of August 7, 2003 (68 FR 47076), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 

[[Page 1301]]

             Table 1.--Estimated Annual Reporting Burden\1\
                No. of      Frequency      Total    Hours per    Total
 Form No.    Respondents       per        Annual     Response    Hours
                            Respondent   Responses
FDA Form    12             7            84          0.40       33.6
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    Submitting a slaughter notice electronically represents a new 
medium for submission of information currently submitted on paper. The 
reporting burden for compilation and submission of this information on 
paper is included in OMB clearance of the information collection 
provisions of Sec.  511.1 (OMB control number 0910-0117). The estimates 
in table 1 of this document reflect the burden associated with putting 
the same information on FDA Form No. 3488 and resulted from discussions 
with sponsors about the time necessary to complete this form.

    Dated: December 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-349 Filed 1-7-04; 8:45 am]