Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research; Establishment of a Public Docket; Request for Comments, 19713-19714 [2013-07576]

Download as PDF Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices 19713 TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC DEVICES/TECHNOLOGY—Continued Focus area Specific areas of interest Manufacturing of chemistry devices ............................................. Clinical Laboratory Improvement Amendments (CLIA) waived devices, blood collection tubes, fecal occult blood devices. Hematology analyzers (specific interest in new technology). Coagulation assays and controls, platelet aggregatometers devices, prothrombin time/international normalized ratio meters and assays, D-Dimer analyzers and assays. Observation of testing in a clinical testing environment. Manufacturing and development of hematology devices ............. Manufacturing and development of coagulation devices ............. Observation of clinical testing in a CLIA high complexity laboratory. B. Site Selection CDRH will be responsible for all travel expenses associated with the site visits. Therefore, selection of potential facilities will be based on the coordination of CDRH’s priorities for staff training and the resources available for this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract to the applicant, that firm must agree to participate in the program and must also have a satisfactory compliance history. public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. DATES: Submit electronic or written comments by September 30, 2013. ADDRESSES: You may submit comments, identified by Docket No. FDA–2013–N– 0305, by any of the following methods: III. Request for Participation Identify requests for participation with the docket number found in the brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2013–N–0305. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read 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. FOR FURTHER INFORMATION CONTACT: Laila Noory, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373 (choose Option 4), FAX: 240–276–3761, email: CTP.3PGovernance@fda.hhs.gov. Dated: March 28, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07593 Filed 4–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0305] srobinson on DSK4SPTVN1PROD with NOTICES Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for data, information, and comments. ACTION: The Food and Drug Administration (FDA) is establishing a SUMMARY: VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 Electronic Submissions Submit electronic comments in the following way: • Electronic Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act). The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding chapter IX (21 U.S.C. 387 et seq.) and grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. FDA expects that tobacco product manufacturers will undertake tobacco product research as part of activities regulated under the Tobacco Control Act, including submission of applications for marketing orders under sections 910 and 911 of the FD&C Act. Section 911 of the FD&C Act requires FDA to issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products (MRTPs). Section 911(l)(2) requires that such regulations or guidance be developed in consultation with the Institute of Medicine (IOM), among others, on the design and conduct of such studies and surveillance. Pursuant to this requirement, the IOM convened a multidisciplinary committee and published a report in December 2011. In the report, entitled ‘‘Scientific Standards for Studies on Modified Risk Tobacco Products’’ (http:// www.iom.edu/Reports/2011/ScientificStandards-for-Studies-on-ModifiedRisk-Tobacco-Products.aspx), the IOM notes that ‘‘governance of research is critical to the production of credible and reliable evidence.’’ Specifically, the IOM report states ‘‘[t]here is profound distrust of the tobacco industry and of research supported by the tobacco industry. This distrust is the direct result of the tobacco industry’s history of improperly influencing or manipulating scientific findings and messaging about the health E:\FR\FM\02APN1.SGM 02APN1 19714 Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices srobinson on DSK4SPTVN1PROD with NOTICES effects of tobacco. This history and the lack of trust may prevent independent experts from participating in research on tobacco products and therefore may impede the production of data on MRTPs necessary to assess public health impact.’’ The IOM also notes that ‘‘the tobacco industry currently lacks the infrastructure and expertise to independently produce the necessary evidence to support an application to market an MRTP.’’ As a result of these findings, the IOM recommends in its report that ‘‘MRTP sponsors should consider use of independent third parties to undertake one or more key functions, including the design and conduct of research, the oversight of specific studies, and the distribution of sponsor funds for research. Such independent third parties should be approved by the FDA in advance of the research.’’ The IOM report focuses on research to support MRTP applications, but FDA is also interested in information on thirdparty governance as it relates more generally to industry-sponsored tobacco research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industrysponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. II. Request for Comments and Information As FDA considers how and whether to implement third-party governance of industry-sponsored tobacco product research, we are requesting comments on the IOM’s recommendation. We encourage you to submit any available research or evidence to support your comments. FDA specifically requests comments on: 1. What are some potential models of third-party governance of industrysponsored tobacco product research? What are the strengths and weaknesses of these models? 2. What criteria could FDA use to evaluate any potential model of thirdparty governance of industry-sponsored tobacco product research? 3. What role would various interested parties (e.g., individual researchers, academic institutions, for-profit and not-for-profit research organizations) play in a third-party governance model of tobacco product research? 4. Who would participate in a thirdparty governance model? How could a governance model be structured to reduce conflict of interest and bias in VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 industry-sponsored tobacco product research? 5. What barriers, if any, would have to be overcome to encourage the broader scientific community to participate in a third-party governance model? 6. Are there unique research challenges faced by small manufacturers and how should they be addressed in a third-party governance model? 7. What kinds of tobacco product research could be subject to third-party governance? For example, could it be applied to: • Product testing? • Nonclinical studies? • Studies in human subjects? (e.g., health effects research, behavioral research, abuse liability studies, consumer perception research) • Computational modeling? • Postmarket surveillance? 8. What aspects of tobacco product research could be subject to third-party governance? For example, should both the design and conduct of research studies be subject to third-party governance? 9. Are there governance models or other steps FDA can take that are more effective for overseeing research to produce generalizable knowledge, such as establishing better testing/research methods and standards, compared to specific product research? III. Submission of Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: March 27, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07576 Filed 4–1–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0051] User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).’’ The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee. The draft of this document was issued on March 16, 2009. DATES: Submit either electronic or written comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002 or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the SUMMARY: E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19713-19714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07576]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0305]


Possible Role of Independent Third Parties in Industry-Sponsored 
Tobacco Product Research; Establishment of a Public Docket; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for data, information, 
and comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket for interested parties to submit to FDA comments on the 
Institute of Medicine's (IOM) recommendation regarding third-party 
governance of industry-sponsored tobacco product research.

DATES: Submit electronic or written comments by September 30, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0305, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Electronic Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0305. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read 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.

FOR FURTHER INFORMATION CONTACT: Laila Noory, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373 (choose Option 4), FAX: 240-276-
3761, email: CTP.3PGovernance@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, President Obama signed into law the Family 
Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco 
Control Act). The Tobacco Control Act amends the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) by adding chapter IX (21 U.S.C. 387 et 
seq.) and grants FDA authority to regulate the manufacture, marketing, 
and distribution of tobacco products to protect public health generally 
and to reduce tobacco use by minors.
    FDA expects that tobacco product manufacturers will undertake 
tobacco product research as part of activities regulated under the 
Tobacco Control Act, including submission of applications for marketing 
orders under sections 910 and 911 of the FD&C Act. Section 911 of the 
FD&C Act requires FDA to issue regulations or guidance (or any 
combination thereof) on the scientific evidence required for assessment 
and ongoing review of modified risk tobacco products (MRTPs). Section 
911(l)(2) requires that such regulations or guidance be developed in 
consultation with the Institute of Medicine (IOM), among others, on the 
design and conduct of such studies and surveillance. Pursuant to this 
requirement, the IOM convened a multidisciplinary committee and 
published a report in December 2011. In the report, entitled 
``Scientific Standards for Studies on Modified Risk Tobacco Products'' 
(http://www.iom.edu/Reports/2011/Scientific-Standards-for-Studies-on-Modified-Risk-Tobacco-Products.aspx), the IOM notes that ``governance 
of research is critical to the production of credible and reliable 
evidence.''
    Specifically, the IOM report states ``[t]here is profound distrust 
of the tobacco industry and of research supported by the tobacco 
industry. This distrust is the direct result of the tobacco industry's 
history of improperly influencing or manipulating scientific findings 
and messaging about the health

[[Page 19714]]

effects of tobacco. This history and the lack of trust may prevent 
independent experts from participating in research on tobacco products 
and therefore may impede the production of data on MRTPs necessary to 
assess public health impact.'' The IOM also notes that ``the tobacco 
industry currently lacks the infrastructure and expertise to 
independently produce the necessary evidence to support an application 
to market an MRTP.''
    As a result of these findings, the IOM recommends in its report 
that ``MRTP sponsors should consider use of independent third parties 
to undertake one or more key functions, including the design and 
conduct of research, the oversight of specific studies, and the 
distribution of sponsor funds for research. Such independent third 
parties should be approved by the FDA in advance of the research.''
    The IOM report focuses on research to support MRTP applications, 
but FDA is also interested in information on third-party governance as 
it relates more generally to industry-sponsored tobacco research. FDA 
is interested in receiving information on whether some form of third-
party governance should be considered for other types of industry-
sponsored tobacco product research, including research to support 
premarket tobacco product applications and other submissions to FDA, as 
well as research designed to contribute to general knowledge regarding 
tobacco products.

II. Request for Comments and Information

    As FDA considers how and whether to implement third-party 
governance of industry-sponsored tobacco product research, we are 
requesting comments on the IOM's recommendation. We encourage you to 
submit any available research or evidence to support your comments. FDA 
specifically requests comments on:
    1. What are some potential models of third-party governance of 
industry-sponsored tobacco product research? What are the strengths and 
weaknesses of these models?
    2. What criteria could FDA use to evaluate any potential model of 
third-party governance of industry-sponsored tobacco product research?
    3. What role would various interested parties (e.g., individual 
researchers, academic institutions, for-profit and not-for-profit 
research organizations) play in a third-party governance model of 
tobacco product research?
    4. Who would participate in a third-party governance model? How 
could a governance model be structured to reduce conflict of interest 
and bias in industry-sponsored tobacco product research?
    5. What barriers, if any, would have to be overcome to encourage 
the broader scientific community to participate in a third-party 
governance model?
    6. Are there unique research challenges faced by small 
manufacturers and how should they be addressed in a third-party 
governance model?
    7. What kinds of tobacco product research could be subject to 
third-party governance? For example, could it be applied to:
     Product testing?
     Nonclinical studies?
     Studies in human subjects? (e.g., health effects research, 
behavioral research, abuse liability studies, consumer perception 
research)
     Computational modeling?
     Postmarket surveillance?
    8. What aspects of tobacco product research could be subject to 
third-party governance? For example, should both the design and conduct 
of research studies be subject to third-party governance?
    9. Are there governance models or other steps FDA can take that are 
more effective for overseeing research to produce generalizable 
knowledge, such as establishing better testing/research methods and 
standards, compared to specific product research?

III. Submission of Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07576 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P