Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program, 30619-30620 [2014-12282]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
(original and update), and verification
audit; names of the person(s) who
completed the self-assessment,
verification audit, risk factor study
(baseline report), risk factor study
(update), and action plan; signature of
the program manager; and date the form
was completed. Form FDA 3520
requires the name and address of the
jurisdiction, contact information for the
enrollee’s designated contact person,
completion date of the self-assessment,
date of the verification audit report,
name of the auditor, signature of the
official completing the form, and date
the form was completed.
The reporting burden in table 5 of this
document includes only the time
necessary to fill out and send the forms,
as compiling the underlying information
(including self-assessment reports,
baseline surveys, outside audits, and
30619
supporting documentation) is accounted
for under the recordkeeping estimates in
table 4 of this document.
In the Federal Register of February 3,
2014 (79 FR 6200), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Activity
Form FDA
Submission of ‘‘FDA National Registry Report’’.
Submission of ‘‘Permission
to Publish in National
Registry’’.
Request for Documentation
of Successful Completion of Staff Training.
3519 ..................................
500
1
500
0.1 (6 minutes)
50
3520 ..................................
500
1
500
0.1 (6 minutes)
50
Conference for Food Protection Training Plan
and Log.
500
3
1,500
0.1 (6 minutes)
150
Total ...........................
...........................................
........................
........................
........................
...........................
250
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimates of the number
of respondents and the hours per
response on its experience with the
Program Standards over the past 14
years. As explained previously in this
document, FDA estimates that no more
than 500 regulatory jurisdictions will
participate in the Program Standards in
any given year. FDA estimates a total of
12 minutes annually for each enrolled
jurisdiction to complete both forms.
FDA bases its estimate on the small
number of data elements on the two
forms and the ease of availability of the
information. FDA estimates that
annually 500 regulatory jurisdictions
will submit one Form FDA 3519 for a
total of 500 annual responses. Each
submission is estimated to take 0.1 hour
(6 minutes) per response for a total of
50 hours. FDA estimates that annually
500 regulatory jurisdictions will submit
one Form FDA 3520 for a total of 500
annual responses. Each of these
submissions is estimated to take 0.1
hour (6 minutes) per response for a total
of 50 hours. FDA estimates that
annually 500 regulatory jurisdictions
will submit 3 requests for
documentation of successful completion
of staff training using the CFP Training
Plan and Log for a total of 1,500 annual
responses. Each submission is estimated
to take 0.1 hour (6 minutes) per
response for a total of 150 hours. Thus,
the total reporting burden for this
information collection is 250 hours.
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12289 Filed 5–27–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0639]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notification of the
Intent To Use an Accredited Person
Under the Accredited Persons
Inspection Program
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
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 eligibility criteria and the process to
SUMMARY:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
be followed by establishments when
notifying FDA of a manufacturer’s intent
to have an accredited third party
conduct a quality systems regulation
inspection of their establishment
instead of FDA, under the Accredited
Persons (AP) Inspection Program.
DATES: Submit either electronic or
written comments on the collection of
information by July 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28MYN1.SGM
28MYN1
30620
Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
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.
Notification of the Intent To Use an
Accredited Person Under the
Accredited Persons Inspection Program
(Formerly Requests for Inspection
Under the Inspection by Accredited
Persons Program)—(OMB Control
Number 0910–0569)—Extension
Section 201 of the Medical Device
User Fee and Modernization Act of 2002
(Public Law 107–250) amended section
704 of the Federal Food, Drug, and
Cosmetic Act by adding subsection (g)
(21 U.S.C. 374(g)). This amendment
authorized FDA to establish a voluntary
third-party inspection program
applicable to manufacturers of class II or
class III medical devices who meet
certain eligibility criteria. In 2007, the
program was modified by the Food and
Drug Administration Amendments Act
of 2007 by revising eligibility criteria
and by no longer requiring prior
approval by FDA. To reflect the
revisions, FDA modified the title of the
collection of information and on March
2, 2009, issued a guidance entitled
‘‘Manufacturer’s Notification of the
Intent to Use an Accredited Person
Under the Accredited Persons
Inspection Program Authorized by
Section 228 of the Food and Drug
Administration Amendments Act of
2007.’’ This guidance supersedes the
Agency’s previous guidance regarding
requests for third-party inspection and
may be found on the Internet at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm085187.htm.
This guidance is intended to assist
device establishments in determining
whether they are eligible to participate
in the AP Program and, if so, how to
submit notification of their intent to use
the program. The AP Program applies to
manufacturers who currently market
their medical devices in the United
States and who also market or plan to
market their devices in foreign
countries. Such manufacturers may
need current inspections of their
establishments to operate in global
commerce.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP Program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
Program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP Program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 20 of these
manufacturers may use an AP in any
given year.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 U.S.C. section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notification regarding use of an accredited person—374(g)
20
1
20
15
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2014–N–0604]
Electronic Submission of
Postmarketing Safety Reports
Involving Vaccine Products; Notice of
Pilot Project
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
The Center for Biologics
Evaluation and Research (CBER) in the
Food and Drug Administration (FDA) is
announcing a pilot project to evaluate
its current systems for receiving
postmarketing safety reports involving
vaccine products electronically for
processing into the Vaccine Adverse
Event Reporting System (VAERS). As
part of this pilot project, CBER also
plans to assess the updated
International Conference on
Harmonization of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
E2B(R3) specification for electronic
transmission of vaccine Individual Case
Safety Reports (ICSRs). Participation in
the pilot project is open to firms that
SUMMARY:
[FR Doc. 2014–12282 Filed 5–27–14; 8:45 am]
AGENCY:
Notice.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
submit postmarketing reports into
VAERS. CBER plans to accept
participation from up to six applicants.
The pilot project is intended to provide
industry and CBER regulatory review
staff with an opportunity to evaluate
current system capabilities for sending
and receiving postmarketing safety
reports for vaccine products using
FDA’s Electronic Submissions Gateway
(ESG), including the use of the updated
ICH E2B(R3) specification.
Submit an electronic request to
participate in this pilot project by June
27, 2014.
DATES:
If you are interested in
participating in this pilot project, you
should submit an electronic request to
CBER_eSubmitter_program@
fda.hhs.gov.
ADDRESSES:
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30619-30620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12282]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0639]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Notification of the Intent To Use an Accredited Person
Under the Accredited Persons Inspection Program
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 eligibility criteria and
the process to be followed by establishments when notifying FDA of a
manufacturer's intent to have an accredited third party conduct a
quality systems regulation inspection of their establishment instead of
FDA, under the Accredited Persons (AP) Inspection Program.
DATES: Submit either electronic or written comments on the collection
of information by July 28, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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
[[Page 30620]]
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.
Notification of the Intent To Use an Accredited Person Under the
Accredited Persons Inspection Program (Formerly Requests for Inspection
Under the Inspection by Accredited Persons Program)--(OMB Control
Number 0910-0569)--Extension
Section 201 of the Medical Device User Fee and Modernization Act of
2002 (Public Law 107-250) amended section 704 of the Federal Food,
Drug, and Cosmetic Act by adding subsection (g) (21 U.S.C. 374(g)).
This amendment authorized FDA to establish a voluntary third-party
inspection program applicable to manufacturers of class II or class III
medical devices who meet certain eligibility criteria. In 2007, the
program was modified by the Food and Drug Administration Amendments Act
of 2007 by revising eligibility criteria and by no longer requiring
prior approval by FDA. To reflect the revisions, FDA modified the title
of the collection of information and on March 2, 2009, issued a
guidance entitled ``Manufacturer's Notification of the Intent to Use an
Accredited Person Under the Accredited Persons Inspection Program
Authorized by Section 228 of the Food and Drug Administration
Amendments Act of 2007.'' This guidance supersedes the Agency's
previous guidance regarding requests for third-party inspection and may
be found on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085187.htm. This
guidance is intended to assist device establishments in determining
whether they are eligible to participate in the AP Program and, if so,
how to submit notification of their intent to use the program. The AP
Program applies to manufacturers who currently market their medical
devices in the United States and who also market or plan to market
their devices in foreign countries. Such manufacturers may need current
inspections of their establishments to operate in global commerce.
There are approximately 8,000 foreign and 10,000 domestic
manufacturers of medical devices. Approximately 5,000 of these firms
only manufacture class I devices and are, therefore, not eligible for
the AP Program. In addition, 40 percent of the domestic firms do not
export devices and therefore are not eligible to participate in the AP
Program. Further, 10 to 15 percent of the firms are not eligible due to
the results of their previous inspection. FDA estimates there are 4,000
domestic manufacturers and 4,000 foreign manufacturers that are
eligible for inclusion under the AP Program. Based on communications
with industry, FDA estimates that on an annual basis approximately 20
of these manufacturers may use an AP in any given year.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification regarding use of an accredited person--374(g)......... 20 1 20 15 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12282 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P
