Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments, 75173-75174 [2012-30511]

Download as PDF 75173 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Type of respondent Total annual responses Average burden per response Total hours Requests to Issue an EUA or a Substantive Amendment to an Existing EUA ......................................................... FDA Review of a Pre-EUA Package or an Amendment Thereto ........................................................................... Manufacturers of an Unapproved EUA Product ................ Public Health Authorities; Unapproved EUA Product ........ 9 1.33 12 33 396 11 5 30 1.45 1.6 3 16 8 90 35 2 2 560 16 180 Total ............................................................................ ........................ .......................... ........................ ........................ 1,152 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Type of respondent Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Manufacturers of an Unapproved EUA Product ................ Public Health Authorities; Unapproved EUA Product ........ 5 30 1.6 3 8 90 25 3 200 270 Total ............................................................................ ........................ .......................... ........................ ........................ 470 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 13, 2012. Leslie Kux, Assistant Commissioner for Policy. assessment will be conducted by an independent contractor in two phases. FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment. [FR Doc. 2012–30513 Filed 12–18–12; 8:45 am] BILLING CODE 4160–01–P Submit electronic or written comments by February 4, 2013. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2012–N–1202] Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013–2017. The assessment is described in section V, ‘‘Independent Assessment of Review Process Management’’, of the commitment letter entitled ‘‘MDUFA Performance Goals and Procedures’’ 1 (MDUFA III Commitment Letter). The sroberts on DSK5SPTVN1PROD with SUMMARY: 1 https://www.fda.gov/downloads/MedicalDevices/ NewsEvents/WorkshopsConferences/ UCM295454.pdf. VerDate Mar<15>2010 18:26 Dec 18, 2012 Jkt 229001 Submit electronic comments 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. All comments should be identified with the docket number found in brackets in the heading of this document. All comments received may be posted without change to https:// 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. ADDRESSES: Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3291, Silver Spring, MD 20993–0002, 301– 796–9384, Amber.Sligar@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Act (Pub. L. 112–144) (FDASIA).2 Title II of FDASIA is MDUFA III, which gives FDA the authority to collect device user fees from industry for fiscal years (FYs) 2013 to 2017. MDUFA III took effect on October 1, 2012, and will sunset in 5 years on October 1, 2017. Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the Agency, whenever they submit an application or a notification to market a new medical device in the United States, and for certain other types of submissions. Under MDUFA III, FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over 5 years. With this additional funding, FDA will be able to hire more than 200 full-time-equivalent workers over the course of MDUFA III. In exchange, FDA has committed to meet certain performance goals outlined in the MDUFA III Commitment Letter. II. Assessment of FDA’s Process for the Review of Device Submissions Section V of the MDUFA III Commitment Letter states that FDA and the device industry will participate in a comprehensive assessment of the process for the review of device applications. The assessment will include consultation with both FDA and industry. The assessment will be conducted in two phases by a private, independent consulting firm, under 2 https://www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW-112publ144.pdf. E:\FR\FM\19DEN1.SGM 19DEN1 sroberts on DSK5SPTVN1PROD with 75174 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices contract with FDA, capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the assessment as described in the MDUFA III Commitment Letter. For Phase 1, FDA will award the contract no later than the end of the second quarter of FY2013. Findings on high-priority recommendations (i.e., those likely to have a significant impact on review times) will be published within 6 months of award; final comprehensive findings and recommendations will be published within 1 year of contract award. FDA will publish an implementation plan within 6 months of receipt of each set of recommendations. For Phase 2 of the independent assessment, the contractor will evaluate the implementation of recommendations and publish a written assessment no later than February 1, 2016. The assessment will address FDA’s premarket review process using an assessment framework that draws from appropriate quality system standards, including, but not limited to, management responsibility, document controls and records management, and corrective and preventive action. The assessment will include, but not be limited to, the following areas: 1. Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards. 2. Analysis of elements of the review process (including the presubmission process, and investigational device exemption, premarket notification (510(k)), and premarket approval application reviews) that consume or save time to facilitate a more efficient process. This includes analysis of root causes for inefficiencies that may affect review performance and total time to decision. This will also include recommended actions to correct any failures to meet MDUFA goals. Analysis of the review process will include the impact of combination products, companion diagnostic products, and laboratory developed tests on the review process. 3. Assessment of FDA methods and controls for collecting and reporting information on premarket review process resource use and performance. 4. Assessment of effectiveness of FDA’s Reviewer Training Program implementation. 5. Recommendations for ongoing periodic assessments and any additional, more detailed or focused assessments. VerDate Mar<15>2010 16:35 Dec 18, 2012 Jkt 229001 FDA will incorporate findings and recommendations, as appropriate, into its management of the premarket review program. FDA will analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and assure its effectiveness. FDA also will incorporate the results of the assessment into a Good Review Management Practices (GRMP) guidance document. FDA’s implementation of the GRMP guidance will include initial and ongoing training of FDA staff, and periodic audits of compliance with the guidance. FDA is seeking public comment now on the proposed statement of work for the assessment, available at https:// www.fda.gov/downloads/ MedicalDevices/ DeviceRegulationandGuidance/ Overview/MDUFAIII/UCM331516.pdf. III. Comments Interested persons may submit either written comments regarding the statement of work to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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: December 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30511 Filed 12–18–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1168] Draft Guidance for Industry on Providing Submissions in Electronic Format—Summary Level Clinical Site Data for Center for Drug Evaluation and Research’s Inspection Planning; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Submissions in Electronic Format— SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Summary Level Clinical Site Data for CDER’s Inspection Planning.’’ The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA’s Center for Drug Evaluation and Research (CDER). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment 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 February 19, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft 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. FOR FURTHER INFORMATION CONTACT: Paul Okwesili, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5353, Silver Spring, MD 20993–0002, 301–796–0173. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER’s Inspection Planning.’’ FDA is responsible for making regulatory decisions about drugs and E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75173-75174]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30511]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1202]


Comprehensive Assessment of the Process for the Review of Device 
Submissions; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the statement of work for an 
assessment of the process for the review of medical device submissions. 
The assessment is part of the FDA performance commitments relating to 
the Medical Device User Fee Amendments of 2012 (MDUFA III), which 
reauthorized device user fees for fiscal years 2013-2017. The 
assessment is described in section V, ``Independent Assessment of 
Review Process Management'', of the commitment letter entitled ``MDUFA 
Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). 
The assessment will be conducted by an independent contractor in two 
phases. FDA is providing a period of 30 days for public comment on the 
statement of work before requesting proposals for the assessment.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.

---------------------------------------------------------------------------
DATES: Submit electronic or written comments by February 4, 2013.

ADDRESSES: Submit electronic comments 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. All comments should be identified with the docket 
number found in brackets in the heading of this document. All comments 
received may be posted without change to https://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.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3291, 
Silver Spring, MD 20993-0002, 301-796-9384, Amber.Sligar@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed into law the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA).\2\ 
Title II of FDASIA is MDUFA III, which gives FDA the authority to 
collect device user fees from industry for fiscal years (FYs) 2013 to 
2017. MDUFA III took effect on October 1, 2012, and will sunset in 5 
years on October 1, 2017.
---------------------------------------------------------------------------

    \2\ https://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.
---------------------------------------------------------------------------

    Device user fees were first established by Congress in 2002. 
Medical device companies pay fees to FDA when they register their 
establishment and list their devices with the Agency, whenever they 
submit an application or a notification to market a new medical device 
in the United States, and for certain other types of submissions. Under 
MDUFA III, FDA is authorized to collect user fees that will total 
approximately $595 million (plus adjustments for inflation) over 5 
years. With this additional funding, FDA will be able to hire more than 
200 full-time-equivalent workers over the course of MDUFA III. In 
exchange, FDA has committed to meet certain performance goals outlined 
in the MDUFA III Commitment Letter.

II. Assessment of FDA's Process for the Review of Device Submissions

    Section V of the MDUFA III Commitment Letter states that FDA and 
the device industry will participate in a comprehensive assessment of 
the process for the review of device applications. The assessment will 
include consultation with both FDA and industry. The assessment will be 
conducted in two phases by a private, independent consulting firm, 
under

[[Page 75174]]

contract with FDA, capable of performing the technical analysis, 
management assessment, and program evaluation tasks required to address 
the assessment as described in the MDUFA III Commitment Letter. For 
Phase 1, FDA will award the contract no later than the end of the 
second quarter of FY2013. Findings on high-priority recommendations 
(i.e., those likely to have a significant impact on review times) will 
be published within 6 months of award; final comprehensive findings and 
recommendations will be published within 1 year of contract award. FDA 
will publish an implementation plan within 6 months of receipt of each 
set of recommendations. For Phase 2 of the independent assessment, the 
contractor will evaluate the implementation of recommendations and 
publish a written assessment no later than February 1, 2016.
    The assessment will address FDA's premarket review process using an 
assessment framework that draws from appropriate quality system 
standards, including, but not limited to, management responsibility, 
document controls and records management, and corrective and preventive 
action.
    The assessment will include, but not be limited to, the following 
areas:
    1. Identification of process improvements and best practices for 
conducting predictable, efficient, and consistent premarket reviews 
that meet regulatory review standards.
    2. Analysis of elements of the review process (including the 
presubmission process, and investigational device exemption, premarket 
notification (510(k)), and premarket approval application reviews) that 
consume or save time to facilitate a more efficient process. This 
includes analysis of root causes for inefficiencies that may affect 
review performance and total time to decision. This will also include 
recommended actions to correct any failures to meet MDUFA goals. 
Analysis of the review process will include the impact of combination 
products, companion diagnostic products, and laboratory developed tests 
on the review process.
    3. Assessment of FDA methods and controls for collecting and 
reporting information on premarket review process resource use and 
performance.
    4. Assessment of effectiveness of FDA's Reviewer Training Program 
implementation.
    5. Recommendations for ongoing periodic assessments and any 
additional, more detailed or focused assessments.
    FDA will incorporate findings and recommendations, as appropriate, 
into its management of the premarket review program. FDA will analyze 
the recommendations for improvement opportunities identified in the 
assessment, develop and implement a corrective action plan, and assure 
its effectiveness. FDA also will incorporate the results of the 
assessment into a Good Review Management Practices (GRMP) guidance 
document. FDA's implementation of the GRMP guidance will include 
initial and ongoing training of FDA staff, and periodic audits of 
compliance with the guidance.
    FDA is seeking public comment now on the proposed statement of work 
for the assessment, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM331516.pdf.

III. Comments

    Interested persons may submit either written comments regarding the 
statement of work to the Division of Dockets Management (see ADDRESSES) 
or electronic comments to https://www.regulations.gov. 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: December 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30511 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P
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