Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability, 61103-61105 [2011-25367]
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Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
of comprehensive, accountable primary
care supported by multiple payers. We
are seeking to collaborate with other
payers in select markets and with
approximately 75 primary care practices
in each market over the course of this
4-year initiative. This solicitation is
directed to public and private health
care payers who will respond
individually to the Innovation Center.
Once payers and markets have been
selected, primary care practices will be
recruited and selected in those markets.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5508–N]
Medicare Program; Comprehensive
Primary Care Initiative
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces a
solicitation for health care payer
organizations to participate in the
Comprehensive Primary Care initiative
(CPC), a multipayer model designed to
improve primary care.
DATES: Letter of Intent Submission
Deadlines: Interested organizations must
submit a nonbinding letter of intent
(LOI), which includes an Excel
document identifying preliminary
markets of interest by November 15,
2011 using the LOI template provided
on the Innovation Center Web site at
https://www.innovation.cms.gov/.
Application Submission Deadline:
Applications must be received through
an online portal, on or before 5 p.m.,
Eastern Standard Time (E.S.T) on
January 17, 2012. We reserve the right
to request additional information from
applicants in order to assess their
applications.
SUMMARY:
Letters of Intent should be
submitted electronically in PDF format
via encrypted e-mail to the following email address by the applicable date
specified in the DATES section of this
notice: CPCi@cms.hhs.gov. Letters of
Intent will only be accepted via e-mail.
Applications will only be accepted via
the online application portal.
FOR FURTHER INFORMATION CONTACT:
CPCi@cms.hhs.gov for questions
regarding the aspects of the
Comprehensive Primary Care initiative
or the application process.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
The Centers for Medicare & Medicaid
Services (CMS) are committed to the
three-part aim of better health, better
health care, and lower per-capita costs
for Medicare, Medicaid and Children’s
Health Insurance Program (CHIP)
beneficiaries. One potential mechanism
for achieving this goal is to support
practice redesign in primary care
through payment reform.
The Center for Medicare & Medicaid
Innovation (Innovation Center) is
seeking to strengthen free-standing
primary care capacity by testing a model
VerDate Mar<15>2010
16:42 Sep 30, 2011
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II. Provisions of the Notice
Consistent with its authority under
section 1115A of the Social Security Act
(the Act) as added by section 3021 of the
Affordable Care Act, to test innovative
payment and service delivery models
that reduce spending under Medicare,
Medicaid or CHIP, while preserving or
enhancing the quality of care, the
Innovation Center aims to achieve the
following goals through the
implementation of the Comprehensive
Primary Care (CPC) initiative:
• To collaborate with other payers on
aligned strategies to support the
delivery of comprehensive primary care
services provided by practices
participating in the initiative (as
described in Section D of the
solicitation).
• To test whether a set of
comprehensive primary care functions,
coupled with payment reform, use of
data to guide improvement, and
meaningful use of health information
technology can achieve the three-part
aim of better care, improved health and
reduced costs that could ultimately be
adopted by Medicare and Medicaid
programs.
We will pay a per-beneficiary-permonth care management payment to
each participating primary care
practices for comprehensive primary
care services that the practice provides
to its Medicare fee-for-service
beneficiaries We will offer an
opportunity for participating practices
to share in savings in years 2 through 4
of the program if the market in which
the practice participates experiences
reductions in its reductions in its total
health system costs (a described in
Section F of the solicitation). Each payer
applying for this initiative will propose
a strategy that is aligned with the
Innovation Center’s approach to
supporting comprehensive primary care.
Learning systems will support
participating practices throughout the
initiative. Payer selection criteria are
described in section II of the
Solicitation.
To the extent that States apply, the
Innovation Center will also pay a per-
PO 00000
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61103
beneficiary-per-month care management
payment to primary care on behalf of
Medicaid fee-forservice beneficiaries;
shared savings will not be a part of the
payment methodology for Medicaid feefor–service.
III. Collection of Information
Requirements
Section 1115A(d)(3)of the Act
specifies that the requirements of the
Paperwork Reduction Act of 1995 do
not apply with respect to the testing and
evaluation of payment and service
delivery models or the expansion of
these models under section 1115A of
the Act.
Authority: Section 1115A of the Social
Security Act.
Dated: September 27, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–25356 Filed 9–28–11; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0689]
Draft Guidance for Industry and Food
and Drug Administration Staff; De
Novo Classification Process
(Evaluation of Automatic Class III
Designation); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation).’’ The purpose of this
document is to provide guidance to FDA
staff and industry on the process for the
submission and review of petitions
submitted under the Federal Food,
Drug, and Cosmetic Act (FD&C Act),
also known as the de novo classification
process. FDA is issuing this draft
guidance to provide updated
recommendations for efficient
interaction with FDA, including what
information to submit, when seeking a
path to market for a novel device via the
de novo process. This draft guidance is
not final nor is it in effect at this time.
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
SUMMARY:
E:\FR\FM\03OCN1.SGM
03OCN1
61104
Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 2,
2011. Submit either electronic or
written comments concerning proposed
collection of information by December
2, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ 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 to the Office of Communication,
Outreach and Development (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 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
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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring,
MD 20993–0002, 301–796–5616; 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.
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
A medical device that is of a new type
that FDA has not yet classified based on
risk, and therefore cannot be found to be
substantially equivalent to a legally
marketed predicate device, may remain
in class III even if the risks it presents
are relatively low. This is the scenario
targeted by Congress when it enacted
section 513(f)(2) of the FD&C Act (21
U.S.C. 360c(f)(2)) as part of the Food
and Drug Administration Modernization
Act of 1997 (FDAMA). The process
created by this provision is referred to
in FDAMA as the Evaluation of
Automatic Class III Designation (e.g., the
VerDate Mar<15>2010
16:42 Sep 30, 2011
Jkt 223001
de novo process). Congress included
this section to limit unnecessary
expenditure of FDA and industry
resources that could occur if lower risk
devices were subject to premarket
approval under section 515 of the FD&C
Act (21 U.S.C. 360e).
FDA issued a guidance document to
explain the procedures involved with
the de novo program, which has been in
place since 1998. Over the past 13 years,
even though a number of new medical
devices have been evaluated by FDA
under the de novo process, FDA
believes that the program has been
under-utilized, and has evaluated what
improvements could be made to
enhance the utility and productivity of
the program. FDA evaluated its
extensive experience gained with
respect to the evidence necessary to
conduct comprehensive reviews of de
novo applications. Accordingly, FDA is
issuing this draft guidance to provide
updated recommendations designed to
foster efficient interaction with FDA,
including what information to submit,
when seeking a path to market via the
de novo process. This guidance
describes a mechanism to provide
greater clarity about the suitability of a
device for de novo review, and timely
input on the type of data necessary to
support de novo classification of an
eligible device.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the de novo classification process. 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 draft guidance may do so by using
the Internet. A search capability for all
CDRH 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. To
receive ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation),’’ from CDRH you may
either send an e-mail request to
dsmica@fda.hhs.gov to receive an
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1769 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501–
3502), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Draft Guidance for Industry and Food
and Drug Administration Staff: De Novo
Classification Process (Evaluation of
Automatic Class III Designation)
This draft guidance describes how
FDA’s Center for Devices and
Radiological Health (CDRH) and Center
for Biologics Evaluation and Research
(CBER) intend to implement this
provision of the law. When final, this
document will supersede ‘‘New Section
513(f)(2)—Evaluation of Automatic
Class III Designation, Guidance for
Industry and CDRH Staff’’ dated
February 19, 1998.
The proposed collections of
information are necessary to satisfy the
previously mentioned statutory
requirements for implementing this
voluntary submission program.
E:\FR\FM\03OCN1.SGM
03OCN1
61105
Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of information for de novo petition program
Number of
respondents
Number of
responses per
respondent
per year
Average
burden per
respondent
(in hours)
Total annual
responses
Total hours
CDRH ...................................................................................
CBER ...................................................................................
25
1
1
1
25
1
100
100
2,500
100
Total ..............................................................................
........................
........................
........................
........................
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device
manufacturers seeking to market
medical device products that have been
classified into class III under section
513(f)(2) of the FD&C Act. Based on
FDA’s experience with the de novo
petition program, FDA expects the
program to continue to be utilized as a
viable program in the future. It is
expected that the number of petitions
will increase over its current rate and
reach a steady rate of approximately 26
submissions per year
FDA estimates from past experience
with the de novo petition program that
the complete process involved with the
program takes approximately 100 hours.
This average is based upon estimates by
FDA administrative and technical staff
who are familiar with the requirements
for submission of a de novo petition
(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 2,600 hours.
TABLE 2
Number of respondents
Total burden
hours
annualized
Hourly wage
rate
Total cost
annualized
26 .................................................................................................................................................
100
$150
$390,000
The average to industry per hour for
this type of work is $150, resulting in
a cost of $15,000 per respondent. The
estimated submission cost of $15,000
multiplied by 26 submissions per year
equals $390,000, which is the
aggregated industry reporting cost
annualized.
This draft guidance also refers to
currently approved information
collections found in FDA regulations.
The collections of information in 21
CFR part 807, subpart E, are approved
under OMB control number 0910–0120.
srobinson on DSK4SPTVN1PROD with NOTICES
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
VerDate Mar<15>2010
16:42 Sep 30, 2011
Jkt 223001
Dated: September 27, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–25367 Filed 9–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review: Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget, in
compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35). To request a copy of the
clearance requests submitted to OMB for
review, call the HRSA Reports
Clearance Office at (301) 443–1129. The
following request has been submitted to
OMB for review under the Paperwork
Reduction Act of 1995:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Proposed Project: ADAP Data Report—
[New]
HRSA’s AIDS Drug Assistance
Program (ADAP) is funded through the
Ryan White HIV/AIDS Program, Part B,
of Title XXVI of the Public Health
Service Act, which provides grants to
states and territories. Each of the 50
states, the District of Columbia, Puerto
Rico, and several territories receive
ADAP grants. The ADAP provides
medications for the treatment of HIV/
AIDS. Program funds may also be used
to purchase health insurance for eligible
clients or for services that enhance
access, adherence, and monitoring of
drug treatments.
The Ryan White HIV/AIDS Program
specifies HRSA’s responsibilities in the
administration of grant funds, the
allocation of funds, the evaluation of
programs for the population served, and
the improvement of quality of care.
Accurate records of the grantees
receiving Ryan White HIV/AIDS
Program funding, the services provided,
and the clients served, continue to be
critical issues for the implementation of
the legislation and are necessary for
HRSA to fulfill its responsibilities.
The ADAP Data Report (ADR)
provides data on the characteristics of
ADAP grantees and the clients being
served with program funds. The ADR is
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61103-61105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0689]
Draft Guidance for Industry and Food and Drug Administration
Staff; De Novo Classification Process (Evaluation of Automatic Class
III Designation); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``De Novo Classification
Process (Evaluation of Automatic Class III Designation).'' The purpose
of this document is to provide guidance to FDA staff and industry on
the process for the submission and review of petitions submitted under
the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the
de novo classification process. FDA is issuing this draft guidance to
provide updated recommendations for efficient interaction with FDA,
including what information to submit, when seeking a path to market for
a novel device via the de novo process. This draft guidance is not
final nor is it in effect at this time.
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
[[Page 61104]]
final version of the guidance, submit either electronic or written
comments on the draft guidance by December 2, 2011. Submit either
electronic or written comments concerning proposed collection of
information by December 2, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``De Novo Classification Process (Evaluation
of Automatic Class III Designation)'' 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
to the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 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 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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616;
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.
I. Background
A medical device that is of a new type that FDA has not yet
classified based on risk, and therefore cannot be found to be
substantially equivalent to a legally marketed predicate device, may
remain in class III even if the risks it presents are relatively low.
This is the scenario targeted by Congress when it enacted section
513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)) as part of the Food
and Drug Administration Modernization Act of 1997 (FDAMA). The process
created by this provision is referred to in FDAMA as the Evaluation of
Automatic Class III Designation (e.g., the de novo process). Congress
included this section to limit unnecessary expenditure of FDA and
industry resources that could occur if lower risk devices were subject
to premarket approval under section 515 of the FD&C Act (21 U.S.C.
360e).
FDA issued a guidance document to explain the procedures involved
with the de novo program, which has been in place since 1998. Over the
past 13 years, even though a number of new medical devices have been
evaluated by FDA under the de novo process, FDA believes that the
program has been under-utilized, and has evaluated what improvements
could be made to enhance the utility and productivity of the program.
FDA evaluated its extensive experience gained with respect to the
evidence necessary to conduct comprehensive reviews of de novo
applications. Accordingly, FDA is issuing this draft guidance to
provide updated recommendations designed to foster efficient
interaction with FDA, including what information to submit, when
seeking a path to market via the de novo process. This guidance
describes a mechanism to provide greater clarity about the suitability
of a device for de novo review, and timely input on the type of data
necessary to support de novo classification of an eligible device.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the de novo
classification process. 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 draft guidance may do
so by using the Internet. A search capability for all CDRH 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. To receive ``De
Novo Classification Process (Evaluation of Automatic Class III
Designation),'' from CDRH you may either send an e-mail 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 1769 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501-3502), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Draft Guidance for Industry and Food and Drug Administration Staff: De
Novo Classification Process (Evaluation of Automatic Class III
Designation)
This draft guidance describes how FDA's Center for Devices and
Radiological Health (CDRH) and Center for Biologics Evaluation and
Research (CBER) intend to implement this provision of the law. When
final, this document will supersede ``New Section 513(f)(2)--Evaluation
of Automatic Class III Designation, Guidance for Industry and CDRH
Staff'' dated February 19, 1998.
The proposed collections of information are necessary to satisfy
the previously mentioned statutory requirements for implementing this
voluntary submission program.
[[Page 61105]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Submission of information for de Number of responses per Total annual burden per
novo petition program respondents respondent per responses respondent Total hours
year (in hours)
----------------------------------------------------------------------------------------------------------------
CDRH............................ 25 1 25 100 2,500
CBER............................ 1 1 1 100 100
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents are medical device manufacturers seeking to market
medical device products that have been classified into class III under
section 513(f)(2) of the FD&C Act. Based on FDA's experience with the
de novo petition program, FDA expects the program to continue to be
utilized as a viable program in the future. It is expected that the
number of petitions will increase over its current rate and reach a
steady rate of approximately 26 submissions per year
FDA estimates from past experience with the de novo petition
program that the complete process involved with the program takes
approximately 100 hours. This average is based upon estimates by FDA
administrative and technical staff who are familiar with the
requirements for submission of a de novo petition (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
2,600 hours.
Table 2
----------------------------------------------------------------------------------------------------------------
Total burden
Number of respondents hours Hourly wage Total cost
annualized rate annualized
----------------------------------------------------------------------------------------------------------------
26........................................................... 100 $150 $390,000
----------------------------------------------------------------------------------------------------------------
The average to industry per hour for this type of work is $150,
resulting in a cost of $15,000 per respondent. The estimated submission
cost of $15,000 multiplied by 26 submissions per year equals $390,000,
which is the aggregated industry reporting cost annualized.
This draft guidance also refers to currently approved information
collections found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, are approved under OMB control number 0910-
0120.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: September 27, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-25367 Filed 9-30-11; 8:45 am]
BILLING CODE 4160-01-P
