Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of Comment Period, 60290-60291 [2013-23794]

Download as PDF 60290 Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity Average burden per response Total annual responses Total hours Certification for citizen petitions (505(q)(1)(H)) .............. Certification for petitions for stay of agency action (505(q)(1)(H)). Verification for comments to citizen petitions (505(q)(1)(I)). Verification for comments to petitions for stay of agency action (505(q)(1)(I)). Verification for supplements to citizen petitions (505(q)(1)(I)). Supplements to petitions for stay of agency action ....... Verification for supplements to petitions for stay of agency action (505(q)(1)(I)). Letter withdrawing a petition for stay of agency action .. 26 1 1.15 1 32 1 0.5 (30 min.) ... 0.5 (30 min.) ... 16 .5 9 1.33 12 0.5 (30 min.) ... 6.0 1 1 1 0.5 (30 min.) ... .5 7 1.43 10 0.5 (30 min.) ... 5.0 1 1 1 1 1 1 6 ...................... 0.5 (30 min.) ... 6 0.5 1 1 1 0.5 (30 min.) ... 0.5 Total Hours .............................................................. ........................ ........................ ......................... 1 There [FR Doc. 2013–23886 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0271] Availability of Masked and Deidentified Non-Summary Safety and Efficacy Data; Reopening of Comment Period Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. The Food and Drug Administration (FDA) is reopening the comment period for the notice entitled ‘‘Availability of Masked and Deidentified Non-Summary Safety and Efficacy Data; Request for Comments,’’ which appeared in the Federal Register of June 4, 2013 (78 FR 33421). The Agency is reopening the comment period in response to requests for additional time and to allow interested persons more time to submit comments. DATES: Submit either electronic or written comments by October 31, 2013 ADDRESSES: Submit electronic comments 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. All comments should be identified with the SUMMARY: emcdonald on DSK67QTVN1PROD with NOTICES 35 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 26, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: .......................... VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 docket number found in brackets at the heading of this document. FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., HILL–3110, Silver Spring, MD 20993, 301–796–3603, FAX: 301–431–6351, Nancy.sager@ fda.hhs.gov; Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Aaliyah EavesLeanos, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5435, 301–796– 2948, FAX: 301–847–8510, Aaliyah.Eaves-Leanos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 4, 2013 (78 FR 33421), FDA published a request for public comments from interested persons on the proposed availability of de-identified and masked data derived from medical product applications. In that notice, FDA requested comments by August 5, 2013, on the following topics: (1) What factors should be considered in masking study data (e.g., data fields from regulatory submissions to remove or modify, number of different products to pool within a product class); (2) what limitations, if any, should there be on the Agency’s ability to make available the masked data as described previously; (3) are there any additional factors FDA should consider in deidentifying data in addition to FDA’s requirement to remove any names and other information (e.g., birth date, death date, local geographic information, PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 contact information) that would identify patients or research subjects before disclosing information; (4) would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful; and (5) which situations do you believe disclosing masked data would be most useful to advance public health? The comment period was 60 days, but the Agency has received requests for an additional 30 days for submitting comments. Each request conveyed concern that the 60-day comment period did not allow sufficient time to develop a meaningful or thoughtful response. FDA has considered the requests and will reopen the comment period for an additional 30 days, thus extending the comment period to October 31, 2013. The Agency believes that an additional 30 days allows adequate time for interested persons to submit comments without significantly delaying the Agency’s consideration of these important issues. II. How To Submit 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. E:\FR\FM\01OCN1.SGM 01OCN1 Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices Dated: September 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–23794 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0787] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; 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 ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.’’ Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data, often before the device design is finalized. This guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical study protocol during the early feasibility study. 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 ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002 or Office of Communication, emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 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 docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Dorothy Abel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1204, Silver Spring, MD 20993–0002, 301–796–6366; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background This guidance is intended to provide assistance to FDA staff, clinicians, medical device innovators, and industry on the development and review of IDE applications (21 CFR 812.20) for early feasibility studies of significant risk devices. Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data in a limited number of subjects. During these studies, iterative device modifications are likely to be made based on clinical experience. Early feasibility studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. As with all clinical studies, initiation of an early feasibility study must be justified by an appropriate benefit/risk analysis and adequate human subject protection measures. This guidance discusses the key principles unique to the justification for, and design of, early feasibility studies, and outlines the general principles for preparing and reviewing early feasibility study IDE applications. This guidance is not intended to address all required elements of an IDE application or to provide a comprehensive tutorial on PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 60291 best clinical practices for investigational medical device studies. Concurrent with the publication of this guidance in draft, November 10, 2011 (76 FR 70150), FDA initiated a pilot program for early feasibility study IDE applications (November 10, 2011, 76 FR 70152) to solicit nominations from sponsors of innovative device technologies. In addition to making clarifications within the final guidance in response to comments from the public on the draft guidance, FDA has incorporated changes based on information learned and experiences gained from the pilot program. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the Agency’s current thinking on IDEs for Early Feasibility Medical Device Clinical Studies. 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 using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1782 to 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 812 have been approved under OMB control number 0910–0078; E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60290-60291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0271]


Availability of Masked and De-identified Non-Summary Safety and 
Efficacy Data; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice entitled ``Availability of Masked and De-
identified Non-Summary Safety and Efficacy Data; Request for 
Comments,'' which appeared in the Federal Register of June 4, 2013 (78 
FR 33421). The Agency is reopening the comment period in response to 
requests for additional time and to allow interested persons more time 
to submit comments.

DATES: Submit either electronic or written comments by October 31, 2013

ADDRESSES: Submit electronic comments 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. All comments should be identified with the docket 
number found in brackets at the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., HILL-3110, Silver Spring, MD 20993, 301-796-3603, FAX: 
301-431-6351, Nancy.sager@fda.hhs.gov; Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210; or Aaliyah Eaves-Leanos, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5435, 301-796-2948, FAX: 301-847-8510, 
Aaliyah.Eaves-Leanos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 4, 2013 (78 FR 33421), FDA 
published a request for public comments from interested persons on the 
proposed availability of de-identified and masked data derived from 
medical product applications. In that notice, FDA requested comments by 
August 5, 2013, on the following topics: (1) What factors should be 
considered in masking study data (e.g., data fields from regulatory 
submissions to remove or modify, number of different products to pool 
within a product class); (2) what limitations, if any, should there be 
on the Agency's ability to make available the masked data as described 
previously; (3) are there any additional factors FDA should consider in 
de-identifying data in addition to FDA's requirement to remove any 
names and other information (e.g., birth date, death date, local 
geographic information, contact information) that would identify 
patients or research subjects before disclosing information; (4) would 
regulatory changes facilitate implementation of such a proposal, and if 
so, what changes would be most useful; and (5) which situations do you 
believe disclosing masked data would be most useful to advance public 
health?
    The comment period was 60 days, but the Agency has received 
requests for an additional 30 days for submitting comments. Each 
request conveyed concern that the 60-day comment period did not allow 
sufficient time to develop a meaningful or thoughtful response.
    FDA has considered the requests and will reopen the comment period 
for an additional 30 days, thus extending the comment period to October 
31, 2013. The Agency believes that an additional 30 days allows 
adequate time for interested persons to submit comments without 
significantly delaying the Agency's consideration of these important 
issues.

II. How To Submit 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.


[[Page 60291]]


    Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23794 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P