Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products, 5758-5760 [2016-02000]

Download as PDF 5758 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ‘‘List of Highest Priority Devices for Human Factors Review’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500052 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 820 are approved under OMB control number 0910–0073; the collections of information in 21 CFR part 812 are approved under OMB control number 0910–0078; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814, subparts A through E are approved under OMB control number 0910–0231; the collections of information in 21 CFR part 814, subpart H are approved under OMB control number 0910–0332; the collections of information in 21 CFR parts 801 and 809 are approved under OMB control number 0910–0485; and the collections of information in the guidance document entitled ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’ are approved under OMB control number 0910–0756. Dated: January 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01889 Filed 2–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0429] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 March 4, 2016. SUMMARY: 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0731. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products mstockstill on DSK4VPTVN1PROD with NOTICES OMB Control Number 0910–0731— Extension The Family Smoking Prevention and 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 new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) when appropriate. This guidance is intended to assist persons who seek meetings with FDA relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. The guidance has been revised to provide clarity. In the guidance, the Agency discusses, among other things: • What information FDA recommends persons include in a meeting request; • How and when to submit a request; and • What information FDA recommends persons submit prior to a meeting. This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package in advance of the meeting. The purpose of this proposed information collection is to allow FDA to conduct meetings with tobacco manufacturers, importers, researchers, and investigators in an effective and efficient manner. FDA issued this guidance as a level 2 guidance consistent with FDA’s good guidance practices regulations (21 CFR 10.115). Meeting Requests: The guidance sets forth FDA’s recommendations for materials to be included in a request for a meeting with FDA to discuss the research and development of tobacco products. In the guidance, FDA recommends that the following information be included in the meeting request: 1. Product name and FDA-assigned Submission Tracking Number (if applicable); 2. Product category (e.g., cigarettes, smokeless tobacco) (if applicable); 3. Product use (indicate for consumer use or for further manufacturing); 4. Contact information for the authorized point of contact for the company requesting the meeting; 5. The topic of the meeting being requested (e.g., a new tobacco product application, an application for permission to market an MRTP, or investigational use of a new tobacco product); 6. A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans; 7. A preliminary list of the specific objectives/outcomes expected from the meeting; E:\FR\FM\03FEN1.SGM 03FEN1 5759 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 8. A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item; 9. A preliminary list of specific questions, grouped by discipline (e.g., chemistry, clinical, nonclinical); 10. A list of all individuals who will attend the meeting on behalf of the tobacco product manufacturer, importer, researcher, or investigator, including titles and responsibilities; 11. The date on which the meeting information package will be received by FDA; and 12. Suggested format of the meeting, e.g., conference call, in-person meeting at FDA offices, video conference, or written response, and suggested dates and times for the meeting. Meetings are usually scheduled for 1 hour. This information will be used by the Agency to: (1) Determine the utility of the meeting, (2) identify Agency staff necessary to discuss proposed agenda items, and (3) schedule the meeting. Meeting Information Packages: An individual submitting a meeting information package to FDA in advance of a meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the individual or FDA to be discussed at the meeting. As stated in the guidance, FDA recommends that meeting information packages generally include updates of information that was submitted with the meeting request and, as applicable: 1. Product composition and design data summary; 2. Manufacturing and process control data summary; 3. Nonclinical data summary; 4. Clinical data summary; 5. Behavioral and product use data summary; 6. User and nonuser perception data summary; and 7. Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information (as applicable): a. Study objective(s); b. Study hypotheses; c. Study design; d. Study population (inclusion/exclusion criteria, comparison group(s); e. Human subject protection information, including Institutional Review Board information; f. Primary and secondary endpoints (definition and success criteria); g. Sample size calculation; h. Data collection procedures; i. Duration of follow up and baseline and follow up assessments, and j. Data analysis plan(s). The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency’s experience, reviewing such information is critical to achieving a productive meeting. For the information that was previously submitted in the meeting request, the information package should provide updated information that reflects the most current and accurate information available. Description of Respondents: The respondents to this collection of information are manufacturers, importers, researchers, and investigators of tobacco products who seek to meet with FDA to discuss their plans regarding the development or marketing of a tobacco product. In the Federal Register of September 17, 2015 (80 FR 55855), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Meeting Requests 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 Total .............................................................................. ........................ ........................ ........................ ........................ 1,876 mstockstill on DSK4VPTVN1PROD with NOTICES 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 3 years. In the next 3 years of this collection, FDA estimates that 67 preapplication meetings will be requested. The number is not expected to change, as the public is more experienced in submitting applications for substantial equivalence, requests for nonsubstantial equivalence, etc. 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 VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 requests + 100 year-2 requests + 50 year3 requests ÷ 3). The hours per response, which is the estimated number of hours that a respondent would spend preparing the information recommended by this guidance to be submitted with a meeting request, is estimated to be approximately 10 hours each, and the total burden hours for meeting requests are expected to be 670 hours (10 hours preparation/mailing × 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 E:\FR\FM\03FEN1.SGM 03FEN1 5760 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices that it will take respondents 1,206 hours of time (67 respondents × 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). Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 4, 2016. ADDRESSES: You may submit comments as follows: DATES: Notice of availability; request for comments. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ‘‘Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.’’ When finalized, this draft document will describe the Agency’s intent not to enforce, before September 24, 2021, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to September 24, 2018. In addition, when finalized, this draft guidance will describe the Agency’s intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until September 24, 2018. This draft guidance is not the final version of the guidance nor is it in effect at this time. Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–D–0199 for ‘‘Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov Dated: January 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–02000 Filed 2–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–0199] Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the draft guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Alternatively, you may submit written E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5758-5760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02000]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0429]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance on Meetings 
With Industry and Investigators on the Research and Development of 
Tobacco Products

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 March 
4, 2016.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0731. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 on Meetings With Industry and Investigators on the Research 
and Development of Tobacco Products

OMB Control Number 0910-0731--Extension

    The Family Smoking Prevention and 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 new tobacco product 
before it may be introduced or delivered into interstate commerce. To 
provide assistance with these pathways to market products, FDA will 
meet with tobacco product manufacturers, importers, researchers, and 
investigators (or their representatives) when appropriate. This 
guidance is intended to assist persons who seek meetings with FDA 
relating to their research to inform the regulation of tobacco 
products, or to support the development or marketing of tobacco 
products. The guidance has been revised to provide clarity.
    In the guidance, the Agency discusses, among other things:
     What information FDA recommends persons include in a 
meeting request;
     How and when to submit a request; and
     What information FDA recommends persons submit prior to a 
meeting.
    This guidance describes two collections of information: (1) The 
submission of a meeting request containing certain information and (2) 
the submission of an information package in advance of the meeting. The 
purpose of this proposed information collection is to allow FDA to 
conduct meetings with tobacco manufacturers, importers, researchers, 
and investigators in an effective and efficient manner. FDA issued this 
guidance as a level 2 guidance consistent with FDA's good guidance 
practices regulations (21 CFR 10.115).
    Meeting Requests: The guidance sets forth FDA's recommendations for 
materials to be included in a request for a meeting with FDA to discuss 
the research and development of tobacco products. In the guidance, FDA 
recommends that the following information be included in the meeting 
request:

    1. Product name and FDA-assigned Submission Tracking Number (if 
applicable);
    2. Product category (e.g., cigarettes, smokeless tobacco) (if 
applicable);
    3. Product use (indicate for consumer use or for further 
manufacturing);
    4. Contact information for the authorized point of contact for 
the company requesting the meeting;
    5. The topic of the meeting being requested (e.g., a new tobacco 
product application, an application for permission to market an 
MRTP, or investigational use of a new tobacco product);
    6. A brief statement of the purpose of the meeting, which could 
include a discussion of the types of studies or data to be discussed 
at the meeting, the general nature of the primary questions to be 
asked, and where the meeting fits in the overall product development 
plans;
    7. A preliminary list of the specific objectives/outcomes 
expected from the meeting;

[[Page 5759]]

    8. A preliminary proposed agenda, including an estimate of the 
time needed and a designated speaker for each agenda item;
    9. A preliminary list of specific questions, grouped by 
discipline (e.g., chemistry, clinical, nonclinical);
    10. A list of all individuals who will attend the meeting on 
behalf of the tobacco product manufacturer, importer, researcher, or 
investigator, including titles and responsibilities;
    11. The date on which the meeting information package will be 
received by FDA; and
    12. Suggested format of the meeting, e.g., conference call, in-
person meeting at FDA offices, video conference, or written 
response, and suggested dates and times for the meeting. Meetings 
are usually scheduled for 1 hour.

    This information will be used by the Agency to: (1) Determine the 
utility of the meeting, (2) identify Agency staff necessary to discuss 
proposed agenda items, and (3) schedule the meeting.
    Meeting Information Packages: An individual submitting a meeting 
information package to FDA in advance of a meeting should provide 
summary information relevant to the product and supplementary 
information pertaining to any issue raised by the individual or FDA to 
be discussed at the meeting. As stated in the guidance, FDA recommends 
that meeting information packages generally include updates of 
information that was submitted with the meeting request and, as 
applicable:

    1. Product composition and design data summary;
    2. Manufacturing and process control data summary;
    3. Nonclinical data summary;
    4. Clinical data summary;
    5. Behavioral and product use data summary;
    6. User and nonuser perception data summary; and
    7. Investigational plans for studies and surveillance of the 
tobacco product, including a summary of proposed study protocols 
containing the following information (as applicable):
    a. Study objective(s);
    b. Study hypotheses;
    c. Study design;
    d. Study population (inclusion/exclusion criteria, comparison 
group(s);
    e. Human subject protection information, including Institutional 
Review Board information;
    f. Primary and secondary endpoints (definition and success 
criteria);
    g. Sample size calculation;
    h. Data collection procedures;
    i. Duration of follow up and baseline and follow up assessments, 
and
    j. Data analysis plan(s).

    The purpose of the information package is to provide Agency staff 
the opportunity to adequately prepare for the meeting, including the 
review of relevant data concerning the product. In the Agency's 
experience, reviewing such information is critical to achieving a 
productive meeting. For the information that was previously submitted 
in the meeting request, the information package should provide updated 
information that reflects the most current and accurate information 
available.
    Description of Respondents: The respondents to this collection of 
information are manufacturers, importers, researchers, and 
investigators of tobacco products who seek to meet with FDA to discuss 
their plans regarding the development or marketing of a tobacco 
product.
    In the Federal Register of September 17, 2015 (80 FR 55855), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
                                                Meeting Requests
----------------------------------------------------------------------------------------------------------------
Combining and Sending Meeting                 67               1              67              10             670
 Request Letters for
 Manufacturers, Importers, and
 Researchers....................
----------------------------------------------------------------------------------------------------------------
                                          Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and Submitting Meeting              67               1              67              18           1,206
 Information Packages for
 Manufacturers, Importers, and
 Researchers....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,876
----------------------------------------------------------------------------------------------------------------
\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 3 years.
    In the next 3 years of this collection, FDA estimates that 67 
preapplication meetings will be requested. The number is not expected 
to change, as the public is more experienced in submitting applications 
for substantial equivalence, requests for nonsubstantial equivalence, 
etc.
    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 / 3). The hours per response, 
which is the estimated number of hours that a respondent would spend 
preparing the information recommended by this guidance to be submitted 
with a meeting request, is estimated to be approximately 10 hours each, 
and the total burden hours for meeting requests are expected to be 670 
hours (10 hours preparation/mailing x 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

[[Page 5760]]

that it will take respondents 1,206 hours of time (67 respondents x 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: January 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02000 Filed 2-2-16; 8:45 am]
BILLING CODE 4164-01-P