2010-11453. 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 Request for a Meeting or Teleconference in Electronic Format to the ...

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 (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by June 14, 2010.

ADDRESSES:

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: FDA Desk Officer, FAX: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0452. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-796-3793.

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 Request for a Meeting or Teleconference in Electronic Format to the Center for Veterinary Medicine—(OMB Control Number 0910-0452)—Extension

CVM holds meetings and/or teleconferences when a sponsor requests a presubmission conference under 21 CFR 514.5, or requests a meeting to discuss general questions. Generally, meeting requests are submitted to CVM on paper. However, CVM now allows registered sponsors to submit information electronically, and to request meetings electronically, if they determine this is more efficient and time saving for them. CVM's guidance on “How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM,” provides sponsors with the option to submit a request for a meeting or teleconference as an e-mail attachment by the Internet. The likely respondents are sponsors for new animal drug applications.

In the Federal Register of February 5, 2010 (75 FR 6035), FDA published a 60-day notice requesting public comment on the proposed collection of information.

In response, two comments were received. One comment was completely outside the scope of the notice and the other requested that FDA meet openly with industry rather than closed sessions. Neither comment addressed the paperwork involved in the information collection.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section/ FDA Form 3489	No. of Respondents	Annual Frequency per Response	Total Annual Responses2	Hours per Response	Total Hours
10.64	40	2.4	96	.08	7.7
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Electronic submissions received between January 1, 2008, and December 31, 2008.

The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (40). The number of total annual responses is based on a review of the actual number of such submissions made between January 1, 2008, and December 31, 2008 (96 x hours per response (.08) = 7.7 total hours).

Dated: May 10, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.