Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Guidance for Industry and Food and Drug Administration Staff; Availability, 19672-19673 [2015-08363]

Download as PDF 19672 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices petitions. 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. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–08362 Filed 4–10–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0090] Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; 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 ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.’’ This guidance clarifies FDA’s current policy on balancing premarket and postmarket data collection during the Agency’s review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:02 Apr 10, 2015 Jkt 235001 An electronic copy of the 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 guidance document entitled ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to https://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 docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993–0002, 301–796–5178; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA has long applied postmarket controls as a way to reduce premarket data collection, where appropriate, while assuring that the statutory standard for approval of reasonable assurance of safety and effectiveness is still met. The right balance of premarket and postmarket data collection facilitates timely patient access to important new technology without undermining patient safety. In this guidance, FDA describes existing statutory requirements under the Federal Food, Drug, and Cosmetic Act, its implementing regulations, and FDA policies that support the policy on balancing premarket and postmarket data collection during review of PMAs. In addition, FDA clarifies how the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Agency considers postmarket data as part of the benefit-risk framework described in FDA’s guidance ‘‘Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,’’ issued on March 28, 2012. This guidance provides a resource for industry and FDA staff on how FDA determines when it is appropriate for a sponsor of a PMA to collect some data (clinical or non-clinical) in the postmarket setting, rather than premarket. A draft of this guidance was made available in the Federal Register on April 23, 2014, and the comment period closed July 22, 2014. Changes between the draft and final versions of this guidance include an increased focus on patient outcomes and additional examples to help industry better understand when it may be appropriate to shift data collection from the premarket to postmarket setting. The final guidance also recognizes the potential for use of registry data to satisfy post-approval study requirements. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on balancing premarket and postmarket data collection for devices subject to premarket approval. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1833 to E:\FR\FM\13APN1.SGM 13APN1 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices identify the guidance you are requesting. DEPARTMENT OF HEALTH AND HUMAN SERVICES IV. Paperwork Reduction Act of 1995 Food and Drug Administration This 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 801 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0073; the collections of information in 21 CFR part 822 have been approved under OMB control number 0910–0449; the collection of information in 21 CFR part 860, subpart C have been approved under OMB control number 0910–0138; and the collections of information in the guidance document regarding requests for feedback on medical device submission have been approved under OMB control number 0910–0756. [Docket No. FDA–2014–N–2294] V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. Dated: April 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–08363 Filed 4–10–15; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4164–01–P Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration’s ‘Fresh Empire’ Multicultural Youth Tobacco Prevention Campaign 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 May 13, 2015. 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–NEW and title ‘‘Evaluation of the Food and Drug Administration’s ‘Fresh Empire’ Multicultural Youth Tobacco Prevention Campaign.’’ 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. SUMMARY: Evaluation of the Food and Drug Administration’s ‘Fresh Empire’ Multicultural Youth Tobacco Prevention Campaign (OMB Control Number 0910–NEW) The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111–31) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco VerDate Sep<11>2014 18:02 Apr 10, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 19673 products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing a youth-targeted public education campaign (‘Fresh Empire’) to help prevent tobacco use among multicultural youth and thereby reduce the public health burden of tobacco. The campaign will feature events, advertisements on television and radio and in print, digital communications including social media, and other forms of media. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to reduce tobacco use by minors, FDA requests OMB approval to collect information needed to evaluate FDA’s ‘Fresh Empire’ multicultural youth tobacco prevention campaign. Comprehensive evaluation of FDA’s public education campaigns is needed to ensure campaign messages are effectively received, understood, and accepted by those for whom they are intended. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. FDA plans to evaluate the effectiveness of its multicultural youth tobacco prevention campaign through an outcome evaluation study that will be designed to follow the multiple, discrete waves of media advertising planned for the campaign. The outcome evaluation study consists of a pre-test survey of multicultural youth aged 12 to 17 before campaign launch. The pre-test survey will be followed by ongoing crosssectional surveys of the target audience of youth beginning approximately 3 months following campaign launch. Information will be collected about youth awareness of and exposure to campaign events and advertisements and about tobacco-related knowledge, attitudes, beliefs, intentions, and use. Information will also be collected on demographic variables including age, sex, race/ethnicity, grade level, and primary language. All information will be collected through in-person and Web-based questionnaires. Youth respondents will be recruited from two sources: (1) A sample drawn from 30 U.S. media markets gathered using an addressbased postal mail sampling of U.S. households for the outcome evaluation studies and (2) targeted social media E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19672-19673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08363]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0090]


Balancing Premarket and Postmarket Data Collection for Devices 
Subject to Premarket Approval; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Balancing Premarket and 
Postmarket Data Collection for Devices Subject to Premarket Approval.'' 
This guidance clarifies FDA's current policy on balancing premarket and 
postmarket data collection during the Agency's review of premarket 
approval applications (PMA). Specifically, this guidance outlines how 
FDA considers the role of postmarket information in determining the 
appropriate type and amount of data that should be collected in the 
premarket setting to support premarket approval, while still meeting 
the statutory standard of safety and effectiveness. FDA believes this 
guidance will improve patient access to safe and effective medical 
devices that are important to public health by improving the 
predictability, consistency, transparency, and efficiency of the 
premarket process.

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: An electronic copy of the 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 guidance document entitled 
``Balancing Premarket and Postmarket Data Collection for Devices 
Subject to Premarket Approval'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002 or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.
    Submit electronic comments on the guidance to https://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 docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Aaron Josephson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-
796-5178; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has long applied postmarket controls as a way to reduce 
premarket data collection, where appropriate, while assuring that the 
statutory standard for approval of reasonable assurance of safety and 
effectiveness is still met. The right balance of premarket and 
postmarket data collection facilitates timely patient access to 
important new technology without undermining patient safety.
    In this guidance, FDA describes existing statutory requirements 
under the Federal Food, Drug, and Cosmetic Act, its implementing 
regulations, and FDA policies that support the policy on balancing 
premarket and postmarket data collection during review of PMAs. In 
addition, FDA clarifies how the Agency considers postmarket data as 
part of the benefit-risk framework described in FDA's guidance 
``Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classifications,'' issued 
on March 28, 2012. This guidance provides a resource for industry and 
FDA staff on how FDA determines when it is appropriate for a sponsor of 
a PMA to collect some data (clinical or non-clinical) in the postmarket 
setting, rather than premarket.
    A draft of this guidance was made available in the Federal Register 
on April 23, 2014, and the comment period closed July 22, 2014. Changes 
between the draft and final versions of this guidance include an 
increased focus on patient outcomes and additional examples to help 
industry better understand when it may be appropriate to shift data 
collection from the premarket to postmarket setting. The final guidance 
also recognizes the potential for use of registry data to satisfy post-
approval study requirements.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on balancing premarket and postmarket data 
collection for devices subject to premarket approval. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov or from CBER 
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Balancing Premarket and Postmarket 
Data Collection for Devices Subject to Premarket Approval'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1833 to

[[Page 19673]]

identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 801 have been approved under 
OMB control number 0910-0485; the collections of information in 21 CFR 
part 803 have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 822 have been approved under OMB control number 0910-0449; the 
collection of information in 21 CFR part 860, subpart C have been 
approved under OMB control number 0910-0138; and the collections of 
information in the guidance document regarding requests for feedback on 
medical device submission have been approved under OMB control number 
0910-0756.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://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 https://www.regulations.gov.

    Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08363 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P
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