Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, 41065-41066 [2013-16402]
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41065
Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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.
Draft Guidance for Industry on and
Food and Drug Administration Staff on
Dear Health Care Provider Letters:
Improving Communication of
Important Safety Information—(OMB
Control Number 0910–New)
This draft guidance provides
recommendations on when to use a Dear
Health Care Provider (DHCP) Letter, the
types of information to include in a
DHCP letter, how to organize that
information, and formatting techniques
to make the information more
accessible. The draft guidance is
intended to improve the quality of
DHCP letters to make them more
effective communication tools for new
information about marketed products.
In the Federal Register of November
12, 2010 (75 FR 69449), FDA published
a 60-day notice requesting public
comment on the draft version of this
guidance. Eleven public comments were
received during the comment period
and in nine of the letters the following
two issues were raised. However, the
other two comments did not address the
information collection.
(Comment 1) Section V of the draft
guidance states that the target audience
should be all health care providers who
could not only prescribe the drug, but
who could also dispense or administer
the drugs. The comments call this an
expansion of the target audience, which
would require manufacturers to send
DHCP letters to physicians, nurses,
pharmacists, and other prescribing and
non-prescribing providers.
Manufacturers would also need to seek
out lists of such non-prescribing health
care providers proactively and
disseminate the letters more broadly
than to just physicians. A
recommendation was made to limit the
letters to prescribers only.
(Response) The regulation requires
manufacturers and distributors to mail
important information to ‘‘physicians
and others responsible for patient care’’.
(See 21 CFR 200.5) To the extent this
includes non-prescribing health care
professionals responsible for patient
care, the manufacturers should send
letters to relevant personnel. This is not
an expansion of the scope of the letters,
merely a clarification of the regulation
and a reflection of the health care
system today, which has a variety of
practitioners involved in patient care.
(Comment 2) In Section VI of the draft
guidance, FDA recommends that
companies conduct an evaluation of the
extent to which the target audience
received the DHCP letter and is aware
of the information that was
communicated in the letter. It also asked
manufacturers to assess the impact of
DHCP letters and their impact on
patient behavior. Comments found this
overly burdensome, beyond the
Agency’s statutory authority, and an
unnecessary increase in
correspondence, thereby potentially
diluting the impact of the DHCP letters.
(Response) We agree with the
comments. The final guidance has been
modified to suggest that manufacturers
conduct an evaluation, for their own
use, of the utility of the letters and their
success in reaching the target audiences.
Based on a review of MedWatch
Safety Alerts for 2008 and 2009, we
identified each Dear Health Care
Provider Letter sent and the identity of
each sponsor sending out a Dear Health
Care Provider Letter for each year. We
estimate that we will receive
approximately 30 Dear Health Care
Provider Letters annually from
approximately 25 application holders.
FDA professionals familiar with Dear
Health Care Provider Letters and with
the recommendations in the draft
guidance estimate that it should take an
application holder approximately 100
hours to prepare and send Dear Health
Care Provider Letters in accordance
with the draft guidance. Therefore we
estimate the annual reporting burden as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
1.20
30
100
3,000
Annual Average ...................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
In the draft guidance, we refer to an
earlier guidance for industry entitled
‘‘Using Electronic Means to Distribute
Certain Product Information’’ (71 FR
26102; May 3, 2006). That guidance
referred to previously approved
collections of information found in FDA
regulations that are subject to review by
OMB. The collections of information in
that guidance have been approved
under OMB control number 0910–0249.
Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16445 Filed 7–8–13; 8:45 am]
17:44 Jul 08, 2013
Food and Drug Administration
[Docket No. FDA–2013–N–0795]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Third-Party Review Under the Food
and Drug Administration
Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection associated
with medical devices third-party review
under the Food and Drug
Administration Modernization Act of
1997 (FDAMA).
DATES: Submit either electronic or
written comments on the collection of
information by September 9, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
E:\FR\FM\09JYN1.SGM
09JYN1
41066
Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices
comments on the collection of
information 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.
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: Under the
PRA (44 U.S.C. 3501–3520), 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,
including each proposed extension of an
existing 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.
Medical Devices; Third-Party Review
Under FDAMA—21 U.S.C. 360m (OMB
Control Number 0910–0375)—Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360m),
directing FDA to accredit persons in the
private sector to review certain
premarket notifications (510(k)s).
Participation in this third-party review
program by accredited persons is
entirely voluntary. A third party
wishing to participate will submit a
request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Activity
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Requests for accreditation ...................................................
510(k) reviews conducted by accredited third parties .........
1
10
1
26
1
260
24
40
24
10,400
Total ..............................................................................
........................
........................
........................
........................
10,424
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual records
Average
burden per
recordkeeping
Total hours
510(k) reviews ......................................................................
10
26
260
10
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Reporting
510(k) Reviews Conducted by
Accredited Third Parties
According to FDA’s data, the number
of 510(k)s submitted for third-party
review is approximately 260 annually,
which is 26 annual reviews per each of
the 10 accredited reviewers.
the Agency anticipates approximately
260 submissions of 510(k)s for thirdparty review per year.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2013–N–0796]
[FR Doc. 2013–16402 Filed 7–8–13; 8:45 am]
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II. Recordkeeping
Third-party reviewers are required to
keep records of their review of each
submission. According to FDA’s data,
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Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
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]]>Agencies
[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41065-41066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0795]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Third-Party Review Under the Food and
Drug Administration Modernization Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
associated with medical devices third-party review under the Food and
Drug Administration Modernization Act of 1997 (FDAMA).
DATES: Submit either electronic or written comments on the collection
of information by September 9, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written
[[Page 41066]]
comments on the collection of information 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.
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: Under the PRA (44 U.S.C. 3501-3520), 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, including
each proposed extension of an existing 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.
Medical Devices; Third-Party Review Under FDAMA--21 U.S.C. 360m (OMB
Control Number 0910-0375)--Extension
Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360m), directing FDA to accredit persons
in the private sector to review certain premarket notifications
(510(k)s). Participation in this third-party review program by
accredited persons is entirely voluntary. A third party wishing to
participate will submit a request for accreditation to FDA. Accredited
third-party reviewers have the ability to review a manufacturer's
510(k) submission for selected devices. After reviewing a submission,
the reviewer will forward a copy of the 510(k) submission, along with
the reviewer's documented review and recommendation to FDA. Third-party
reviewers should maintain records of their 510(k) reviews and a copy of
the 510(k) for a reasonable period of time, usually a period of 3
years.
This information collection will allow FDA to continue to implement
the accredited person review program established by FDAMA and improve
the efficiency of 510(k) review for low- to moderate-risk devices.
Respondents to this information collection are businesses or other
for-profit organizations.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation...... 1 1 1 24 24
510(k) reviews conducted by 10 26 260 40 10,400
accredited third parties.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,424
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews..................................................... 10 26 260 10 2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
I. Reporting
510(k) Reviews Conducted by Accredited Third Parties
According to FDA's data, the number of 510(k)s submitted for third-
party review is approximately 260 annually, which is 26 annual reviews
per each of the 10 accredited reviewers.
II. Recordkeeping
Third-party reviewers are required to keep records of their review
of each submission. According to FDA's data, the Agency anticipates
approximately 260 submissions of 510(k)s for third-party review per
year.
Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16402 Filed 7-8-13; 8:45 am]
BILLING CODE 4160-01-P
