81 FR 5758 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 22 (February 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5758-5760 | |
| FR Document | 2016-02000 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Notices] [Pages 5758-5760] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![5758 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
Guidance documents are also available DEPARTMENT OF HEALTH AND will meet with tobacco product
at http://www.regulations.gov. Persons HUMAN SERVICES manufacturers, importers, researchers,
unable to download an electronic copy and investigators (or their
of ‘‘List of Highest Priority Devices for Food and Drug Administration representatives) when appropriate. This
Human Factors Review’’ may send an [Docket No. FDA–2012–D–0429] guidance is intended to assist persons
email request to CDRH-Guidance@ who seek meetings with FDA relating to
fda.hhs.gov to receive an electronic Agency Information Collection their research to inform the regulation of
copy of the document. Please use the Activities; Submission for Office of tobacco products, or to support the
document number 1500052 to identify Management and Budget Review; development or marketing of tobacco
the guidance you are requesting. Comment Request; Guidance on products. The guidance has been
Meetings With Industry and revised to provide clarity.
IV. Paperwork Reduction Act of 1995 Investigators on the Research and In the guidance, the Agency
Development of Tobacco Products discusses, among other things:
This draft guidance refers to
previously approved collections of AGENCY: Food and Drug Administration, • What information FDA
information found in FDA regulations. HHS. recommends persons include in a
These collections of information are meeting request;
ACTION: Notice.
subject to review by the Office of • How and when to submit a request;
Management and Budget (OMB) under SUMMARY: The Food and Drug and
the Paperwork Reduction Act of 1995 Administration (FDA) is announcing • What information FDA
(44 U.S.C. 3501–3520). The collections that a proposed collection of recommends persons submit prior to a
of information in 21 CFR part 820 are information has been submitted to the meeting.
Office of Management and Budget This guidance describes two
approved under OMB control number
(OMB) for review and clearance under collections of information: (1) The
0910–0073; the collections of
the Paperwork Reduction Act of 1995. submission of a meeting request
information in 21 CFR part 812 are
DATES: Fax written comments on the containing certain information and (2)
approved under OMB control number
collection of information by March 4, the submission of an information
0910–0078; the collections of
2016. package in advance of the meeting. The
information in 21 CFR part 807, subpart
E are approved under OMB control ADDRESSES: To ensure that comments on purpose of this proposed information
number 0910–0120; the collections of the information collection are received, collection is to allow FDA to conduct
information in 21 CFR part 814, OMB recommends that written meetings with tobacco manufacturers,
subparts A through E are approved comments be faxed to the Office of importers, researchers, and investigators
under OMB control number 0910–0231; Information and Regulatory Affairs, in an effective and efficient manner.
OMB, Attn: FDA Desk Officer, FAX: FDA issued this guidance as a level 2
the collections of information in 21 CFR
202–395–7285, or emailed to oira_ guidance consistent with FDA’s good
part 814, subpart H are approved under
submission@omb.eop.gov. All guidance practices regulations (21 CFR
OMB control number 0910–0332; the 10.115).
comments should be identified with the
collections of information in 21 CFR
OMB control number 0910–0731. Also Meeting Requests: The guidance sets
parts 801 and 809 are approved under
include the FDA docket number found forth FDA’s recommendations for
OMB control number 0910–0485; and in brackets in the heading of this materials to be included in a request for
the collections of information in the document. a meeting with FDA to discuss the
guidance document entitled ‘‘Requests research and development of tobacco
for Feedback on Medical Device FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food products. In the guidance, FDA
Submissions: The Pre-Submission recommends that the following
Program and Meetings with Food and and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver information be included in the meeting
Drug Administration Staff’’ are request:
Spring, MD 20993–0002, PRAStaff@
approved under OMB control number
fda.hhs.gov. 1. Product name and FDA-assigned
0910–0756. Submission Tracking Number (if applicable);
SUPPLEMENTARY INFORMATION: In
Dated: January 28, 2016. 2. Product category (e.g., cigarettes,
compliance with 44 U.S.C. 3507, FDA smokeless tobacco) (if applicable);
Leslie Kux, has submitted the following proposed 3. Product use (indicate for consumer use
Associate Commissioner for Policy. collection of information to OMB for or for further manufacturing);
[FR Doc. 2016–01889 Filed 2–2–16; 8:45 am] review and clearance. 4. Contact information for the authorized
BILLING CODE 4164–01–P point of contact for the company requesting
Guidance on Meetings With Industry the meeting;
and Investigators on the Research and 5. The topic of the meeting being requested
Development of Tobacco Products (e.g., a new tobacco product application, an
application for permission to market an
OMB Control Number 0910–0731—
MRTP, or investigational use of a new
Extension tobacco product);
The Family Smoking Prevention and 6. A brief statement of the purpose of the
meeting, which could include a discussion of
mstockstill on DSK4VPTVN1PROD with NOTICES
Tobacco Control Act (Pub. L. 111–31)
offers tobacco product manufacturers the types of studies or data to be discussed
several pathways to obtain an order at the meeting, the general nature of the
primary questions to be asked, and where the
from FDA to authorize the marketing of meeting fits in the overall product
a new tobacco product before it may be development plans;
introduced or delivered into interstate 7. A preliminary list of the specific
commerce. To provide assistance with objectives/outcomes expected from the
these pathways to market products, FDA meeting;
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![5760 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
that it will take respondents 1,206 hours DATES: Although you can comment on or at the Division of Dockets
of time (67 respondents × 18 hours) to any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
gather, copy, and submit brief 10.115(g)(5)), to ensure that the Agency Monday through Friday.
statements about the product, a considers your comments on this draft • Confidential Submissions—To
description of the details of the guidance before it begins work on the submit a comment with confidential
anticipated meeting, and data and final version of the guidance, submit information that you do not wish to be
information that generally would either electronic or written comments made publicly available, submit your
already have been generated for the on the draft guidance by April 4, 2016. comments only as a written/paper
planned research and/or product ADDRESSES: You may submit comments submission. You should submit two
development. as follows: copies total. One copy will include the
The total number of burden hours for information you claim to be confidential
Electronic Submissions with a heading or cover note that states
this collection of information is 1,876
hours (670 hours to prepare and submit Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
meeting requests and 1,206 hours to following way: CONFIDENTIAL INFORMATION.’’ The
prepare and submit information • Federal eRulemaking Portal: http:// Agency will review this copy, including
packages). www.regulations.gov. Follow the the claimed confidential information, in
instructions for submitting comments. its consideration of comments. The
Dated: January 29, 2016. Comments submitted electronically, second copy, which will have the
Leslie Kux, including attachments, to http:// claimed confidential information
Associate Commissioner for Policy. www.regulations.gov will be posted to redacted/blacked out, will be available
[FR Doc. 2016–02000 Filed 2–2–16; 8:45 am] the docket unchanged. Because your for public viewing and posted on
BILLING CODE 4164–01–P comment will be made public, you are http://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Division of Dockets
comment does not include any Management. If you do not wish your
DEPARTMENT OF HEALTH AND confidential information that you or a name and contact information to be
HUMAN SERVICES third party may not wish to be posted, made publicly available, you can
such as medical information, your or provide this information on the cover
Food and Drug Administration anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
[Docket No. FDA–2016–D–0199] as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Enforcement Policy on National Health information, or other information that will not be disclosed except in
Related Item Code and National Drug identifies you in the body of your accordance with 21 CFR 10.20 and other
Code Numbers Assigned to Devices; comments, that information will be applicable disclosure law. For more
Draft Guidance for Industry and Food posted on http://www.regulations.gov. information about FDA’s posting of
and Drug Administration Staff; • If you want to submit a comment comments to public dockets, see 80 FR
Availability and Request for Comments with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
AGENCY: Food and Drug Administration, regulatoryinformation/dockets/
public, submit the comment as a
HHS. default.htm.
written/paper submission and in the
ACTION:Notice of availability; request manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
for comments. Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
SUMMARY: The Food and Drug Written/Paper Submissions received, go to http://
Administration (FDA) is announcing the Submit written/paper submissions as www.regulations.gov and insert the
availability of the draft guidance for follows: docket number, found in brackets in the
industry and FDA staff entitled • Mail/Hand delivery/Courier (for heading of this document, into the
‘‘Enforcement Policy on National Health written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Related Item Code and National Drug Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Code Numbers Assigned to Devices.’’ and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
When finalized, this draft document Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
will describe the Agency’s intent not to • For written/paper comments An electronic copy of the draft
enforce, before September 24, 2021, the submitted to the Division of Dockets guidance document is available for
prohibition against providing National Management, FDA will post your download from the Internet. See the
Health Related Item Code (NHRIC) or comment, as well as any attachments, SUPPLEMENTARY INFORMATION section for
National Drug Code (NDC) numbers on except for information submitted, information on electronic access to the
device labels and device packages, with marked and identified, as confidential, guidance. Submit written requests for a
respect to certain finished devices if submitted as detailed in single hard copy of the draft guidance
manufactured and labeled prior to ‘‘Instructions.’’ document entitled ‘‘Enforcement Policy
September 24, 2018. In addition, when Instructions: All submissions received on National Health Related Item Code
finalized, this draft guidance will must include the Docket No. FDA– and National Drug Code Numbers
mstockstill on DSK4VPTVN1PROD with NOTICES
describe the Agency’s intent to continue 2016–D–0199 for ‘‘Enforcement Policy Assigned to Devices’’ to the Office of the
considering requests for continued use on National Health Related Item Code Center Director, Guidance and Policy
of FDA labeler codes under a system for and National Drug Code Numbers Development, Center for Devices and
the issuance of unique device identifiers Assigned to Devices.’’ Received Radiological Health (CDRH), Food and
(UDIs) until September 24, 2018. This comments will be placed in the docket Drug Administration, 10903 New
draft guidance is not the final version of and, except for those submitted as Hampshire Ave., Bldg. 66, Rm. 5431,
the guidance nor is it in effect at this ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002.
time. viewable at http://www.regulations.gov Alternatively, you may submit written
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Document Created: 2016-02-03 00:39:56
Document Modified: 2016-02-03 00:39:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by March 4, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 5758 |
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