Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff, 73662-73663 [2012-29788]
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Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
Dated: December 4, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[FR Doc. 2012–29908 Filed 12–10–12; 8:45 am]
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Occupational Safety and
Health Education and Research Centers
(ERC) PAR 10–217, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
tkelley on DSK3SPTVN1PROD with
Times and Dates:
8:00 a.m.–5:00 p.m., February 26,
2013 (Closed).
8:00 a.m.–5:00 p.m., February 27, 2013
(Closed).
8:00 a.m.–12:00 p.m., February 28, 2013
(Closed).
Place: Renaissance Atlanta Midtown
Hotel, 866 W. Peachtree Street, NW.,
Atlanta, Georgia 30308, Telephone:
(678) 412–2400.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters To Be Discussed: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Occupational Safety and Health
Education and Research Centers (ERC)
PAR 10–217.’’
Contact Person for More Information:
George Bockosh, M.S., Scientific Review
Officer, CDC/NIOSH, 626 Cochrans Mill
Road, Mailstop P–05, Pittsburgh,
Pennsylvania 15236, Telephone: (412)
386–6465; Joan Karr, Ph.D., Scientific
Review Officer, CDC/NIOSH 1600
Clifton Road, Mailstop E–74, Atlanta,
Georgia 30333, Telephone: (404) 498–
2506.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Medical Devices: The Pre-Submission
Program and Meetings With FDA Staff
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 January 10,
2013.
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: ‘‘Medical Devices: The PreSubmission Program and Meetings with
FDA Staff.’’ Also, include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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:
Guidance on Medical Devices: PreSubmission Program and Meetings with
FDA Staff—(OMB Control Number
0910–NEW)
This guidance describes the PreSubmission program for medical
PO 00000
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devices reviewed in the Center for
Devices and Radiological Health (CDRH)
and the Center for Biologics Evaluation
and Research (CBER). The guidance
provides recommendations regarding
the information that should be
submitted in a Pre-Submission Package
and procedures that should be followed
for meetings between CDRH and CBER
staff and industry representatives or
application sponsors. When approved
by OMB, this guidance document will
supersede ‘‘Pre-IDE Program: Issues and
Answers—Blue Book Memo D99–1’’
dated March 25, 1999.
A Pre-Submission is defined as a
formal written request from an applicant
for feedback from FDA to be provided
in the form of a formal written response
or, if the manufacturer chooses, a
meeting or teleconference in which the
feedback is documented in meeting
minutes. A Pre-Submission is
appropriate when FDA’s feedback on
specific questions is necessary to guide
product development and/or
application preparation. The proposed
collections of information are necessary
to allow the Agency to receive PreSubmission Packages in order to
implement this voluntary submission
program.
Over time, the FDA preinvestigational device exemption (preIDE) program evolved to include
feedback on premarket approval (PMA)
applications, humanitarian device
exemption applications, and 510(k)
submissions, as well as to address
questions related to whether a clinical
study requires submission of an IDE.
During discussions with representatives
of the medical device industry in the
development of the Agency’s
recommendations for Medical Device
User Fee Amendments 2012 (MDUFA
III), both the industry and the Agency
agreed that the Pre-Submission
(formerly pre-IDE) process provided
important additional transparency to the
IDE and premarket review processes. In
response, the Secretary’s 2012
Commitment Letter to Congress
(MDUFA III Commitment Letter)
included FDA’s commitment to institute
a structured process for managing PreSubmissions.
To fulfill the Secretary’s commitment
to the to industry, this final guidance:
(1) Describes the Pre-Submission
program (formerly the IDE program) for
medical devices reviewed in CDRH and
CBER; (2) assists device manufacturers
and their representatives who seek
meetings with the FDA by providing
guidance and recommendations
regarding information that should be
included in a Pre-Submission Package;
and (3) provides guidance as to the
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73663
Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
procedures that CDRH and CBER intend
to follow when industry representatives
or application sponsors request a
meeting with review staff.
In the Federal Register of July 13,
2012 (77 FR 41413), FDA published a
notice of availability combined with a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no PRArelated comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA Center
Annual
frequency
per response
Total annual
responses
Hours per
response
Total
hours
CDRH ...................................................................................
CBER ...................................................................................
2,465
79
1
1
2,465
79
137
137
337,705
10,823
Total ..............................................................................
........................
........................
........................
........................
348,528
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device
manufacturers subject to FDA’s laws
and regulations. FDA estimates that it
will receive approximately 2,544 presubmission packages annually. The
Agency reached this estimate by
reviewing the number of submissions
received by the Agency under the PreIDE program over the past 10 years.
Based on FDA’s experience with the
Pre-IDE program, FDA expects the Pre-
Submission program to continue to be
utilized as a viable program in the
future and expects that the number of
pre-submission packages will increase
over its current rate and reach a steady
state of approximately 2,544
submissions per year.
FDA estimates from past experience
with the Pre-IDE program that the
complete process involved with the
program takes approximately 137 hours.
This average is based upon estimates by
FDA administrative and technical staff
that is familiar with the requirements
for submission of a Pre-Submission and
related materials, have consulted and
advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Therefore, the total reporting burden
hours is estimated to be 348,528 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Hourly wage rate
Total cost annualized
2,544
1 There
Total burden hours annualized
137
$150
$52,279,200
are no capital costs or operating and maintenance costs associated with this collection of information.
The average to industry per hour for
this type of work is $150, resulting in
a cost of $20,550 per respondent. The
estimated submission cost of $20,550
multiplied by 2,544 submissions per
year equals $52,279,200, which is the
aggregated industry reporting cost
annualized.
FDA’s annual estimate of 2,544
submissions is based on experienced
trends over the past several years. FDA’s
administrative and technical staffs, who
are familiar with the requirements for
current pre-submissions, estimate that
an average of 137 hours is required to
prepare a pre-submission. However, we
recognize there is a variance in the
preparation submission because of the
vast and varying complexities of
medical devices.
tkelley on DSK3SPTVN1PROD with
Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–29788 Filed 12–10–12; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0304]
Susan F. Knott; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a
request for a hearing submitted by
Susan F. Knott and is issuing an order
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Knott for 2 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Knott was
convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
SUMMARY:
PO 00000
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In determining the appropriateness and
period of Knott’s debarment, FDA has
considered the relevant factors listed in
the FD&C Act. Knott has failed to file
with the Agency information and
analyses sufficient to create a basis for
a hearing concerning this action.
DATES: The order is effective December
11, 2012.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–4613.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a misdemeanor under
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]]>Agencies
[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73662-73663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Medical
Devices: The Pre-Submission Program and Meetings With FDA Staff
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 January
10, 2013.
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: ``Medical Devices: The Pre-Submission Program and Meetings with
FDA Staff.'' Also, include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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.
Guidance on Medical Devices: Pre-Submission Program and Meetings with
FDA Staff--(OMB Control Number 0910-NEW)
This guidance describes the Pre-Submission program for medical
devices reviewed in the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER). The
guidance provides recommendations regarding the information that should
be submitted in a Pre-Submission Package and procedures that should be
followed for meetings between CDRH and CBER staff and industry
representatives or application sponsors. When approved by OMB, this
guidance document will supersede ``Pre-IDE Program: Issues and
Answers--Blue Book Memo D99-1'' dated March 25, 1999.
A Pre-Submission is defined as a formal written request from an
applicant for feedback from FDA to be provided in the form of a formal
written response or, if the manufacturer chooses, a meeting or
teleconference in which the feedback is documented in meeting minutes.
A Pre-Submission is appropriate when FDA's feedback on specific
questions is necessary to guide product development and/or application
preparation. The proposed collections of information are necessary to
allow the Agency to receive Pre-Submission Packages in order to
implement this voluntary submission program.
Over time, the FDA pre-investigational device exemption (pre-IDE)
program evolved to include feedback on premarket approval (PMA)
applications, humanitarian device exemption applications, and 510(k)
submissions, as well as to address questions related to whether a
clinical study requires submission of an IDE. During discussions with
representatives of the medical device industry in the development of
the Agency's recommendations for Medical Device User Fee Amendments
2012 (MDUFA III), both the industry and the Agency agreed that the Pre-
Submission (formerly pre-IDE) process provided important additional
transparency to the IDE and premarket review processes. In response,
the Secretary's 2012 Commitment Letter to Congress (MDUFA III
Commitment Letter) included FDA's commitment to institute a structured
process for managing Pre-Submissions.
To fulfill the Secretary's commitment to the to industry, this
final guidance: (1) Describes the Pre-Submission program (formerly the
IDE program) for medical devices reviewed in CDRH and CBER; (2) assists
device manufacturers and their representatives who seek meetings with
the FDA by providing guidance and recommendations regarding information
that should be included in a Pre-Submission Package; and (3) provides
guidance as to the
[[Page 73663]]
procedures that CDRH and CBER intend to follow when industry
representatives or application sponsors request a meeting with review
staff.
In the Federal Register of July 13, 2012 (77 FR 41413), FDA
published a notice of availability combined with a 60-day notice
requesting public comment on the proposed collection of information.
FDA received no PRA-related comments.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
FDA Center Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
CDRH............................ 2,465 1 2,465 137 337,705
CBER............................ 79 1 79 137 10,823
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 348,528
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA estimates that it will receive approximately 2,544
pre-submission packages annually. The Agency reached this estimate by
reviewing the number of submissions received by the Agency under the
Pre-IDE program over the past 10 years. Based on FDA's experience with
the Pre-IDE program, FDA expects the Pre-Submission program to continue
to be utilized as a viable program in the future and expects that the
number of pre-submission packages will increase over its current rate
and reach a steady state of approximately 2,544 submissions per year.
FDA estimates from past experience with the Pre-IDE program that
the complete process involved with the program takes approximately 137
hours. This average is based upon estimates by FDA administrative and
technical staff that is familiar with the requirements for submission
of a Pre-Submission and related materials, have consulted and advised
manufacturers on these requirements, and have reviewed the
documentation submitted.
Therefore, the total reporting burden hours is estimated to be
348,528 hours.
Table 2--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------
Number of Total burden Total cost
respondents hours annualized Hourly wage rate annualized
------------------------------------------------------------------------
2,544 137 $150 $52,279,200
------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
The average to industry per hour for this type of work is $150,
resulting in a cost of $20,550 per respondent. The estimated submission
cost of $20,550 multiplied by 2,544 submissions per year equals
$52,279,200, which is the aggregated industry reporting cost
annualized.
FDA's annual estimate of 2,544 submissions is based on experienced
trends over the past several years. FDA's administrative and technical
staffs, who are familiar with the requirements for current pre-
submissions, estimate that an average of 137 hours is required to
prepare a pre-submission. However, we recognize there is a variance in
the preparation submission because of the vast and varying complexities
of medical devices.
Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29788 Filed 12-10-12; 8:45 am]
BILLING CODE 4160-01-P
