This PDF is the current document as it appeared on Public Inspection on 12/12/2012 at 08:45 am.
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.
Fax written comments on the collection of information by January 14, 2013.
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: 202-395-7285, or emailed to firstname.lastname@example.org. All comments should be identified with the OMB control number 0910-NEW and title “Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products.” Also, include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products—(OMB Control Number 0910-NEW)
This guidance is intended to assist tobacco manufacturers, importers, researchers, and investigators, and their representatives who seek meetings with staff of FDA's Center for Tobacco Products (CTP) relating to their plans to conduct research to inform the regulation of tobacco products or support the development or marketing of tobacco products. This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market particular products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance is intended to assist persons who seek guidance relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. In the guidance, the Agency discusses, among other things:
- What information DA recommends persons include in such a meeting request;
- How and when to submit such a request; and
- What information FDA recommends persons submit prior to such a meeting.
In the Federal Register of May 25, 2012 (77 FR 31368), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one response containing PRA-related comments.. The comment indicated that the guidance should clarify that meeting request times will vary depending on the type of submission to be discussed and the meeting information package requirements should be tailored to the submission type.
In response, the estimated burden hours for both meeting requests and meeting information package requirements have been calculated by FDA and are based on an average number of hours for each type of submission over a 3-year period. The meeting information requirements are also averaged together and are not individually split into submission types for this collection. The commenter also provided comments that were not PRA-related and are beyond the scope of this document.
FDA estimates the burden of this collection of information as follows:
|Meeting requests and information packages||Number of respondents||Number of responses per respondent||Total annual responses||Average burden per response (in hours)||Total hours|
|Combining and sending meeting request letters for manufacturers, importers, and researchers||67||1||67||10||670|
|Meeting Information Packages|
|Combining and submitting meeting information packages for manufacturers, importers, and researchers.||67||1||67||18||1,206|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
FDA's estimate of the number of respondents for meeting requests in table 1 of this document is based on the number of meeting requests to be received over the next three years. In year 1 of this collection, FDA estimates that 50 preapplication meetings will be requested. In year 2, FDA estimates that 100 meetings will be requested, especially as applications and reports for substantial equivalence, etc., are received and acted upon. Once the public knows more about submitting these applications in year 3 three, the request for meetings is expected to drop back to the year 1 one rate of 50 per year. Thus, FDA estimates the number of manufacturers, importers, researchers, and investigators who are expected to submit meeting requests in table 1 of this document to be 67 (50 year 1 requests + 100 year 2 requests + 50 year 3 requests divided by 3). The hours per response, which is the estimated number of hours that a respondent would spend preparing the information recommended by the guidance to be submitted with a meeting request, is estimated to be approximately 10 hours each, and the total burden hours are 670 hours (10 hours preparation/mailing times 67 average respondents per year). Based on FDA's experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting.
FDA's estimate of the number of respondents for compiling meeting information packages in table 1 of this document is based on 67 respondents each preparing copies of their information package and submitting them to FDA, for a total of 1,206 hours annually. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package as recommended by the guidance, is estimated to be approximately 18 hours per information package. Based on FDA's experience, the Agency expects that it will take respondents 1,206 hours of time (67 respondents times 18 hours) to gather, copy, and submit brief statements about the product, a description of the details of the anticipated meeting, and data and information that generally would already have been generated for the planned research and/or product development. The total number of burden hours for this collection of information is 1,876 hours (670 hours to prepare and submit meeting requests and 1,206 hours to prepare and submit information packages).
Dated: December 7, 2012.
Assistant Commissioner for Policy.
[FR Doc. 2012-30057 Filed 12-12-12; 8:45 am]
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