Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening of the Comment Period, 29765-29766 [2011-12617]
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29765
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
to have an accredited third party
conduct a quality systems regulation
inspection of their establishment
instead of FDA, under the inspections
by the Accredited Persons (AP)
Program.
DATES: Submit either electronic or
written comments on the collection of
information by July 22, 2011.
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:
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.
Requests for Inspection Under the
Inspection by Accredited Persons
Program—21 U.S.C. 374(g) (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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 U.S.C. Section
Number of
respondents
Number of
responses per
respondent
Total annual
respondents
Average
burden per
response
(in hours)
Total hours
374(g) ...................................................................................
100
1
100
15
1,500
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
inclusion under the AP Program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 100 of these
manufacturers may use an AP in any
given year.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Determination of System Attributes for
the Tracking and Tracing of
Prescription Drugs; Reopening of the
Comment Period
[FR Doc. 2011–12552 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Food and Drug Administration
[Docket No. FDA–2010–N–0633]
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
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29766
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of public
workshop published in the Federal
Register of January 7, 2011 (76 FR
1182). In that notice, FDA announced a
public workshop that took place on
February 15 and 16, 2011, and requested
public comment regarding the topics
discussed at the workshop on
determining system attributes for
tracking and tracing prescription drugs.
The workshop provided a forum for
discussing possible approaches to
developing a track-and-trace system and
for obtaining input from supply chain
partners on potential attributes and
standards for the identification,
authentication, and tracking and tracing
of prescription drug packages. FDA is
reopening the comment period to allow
additional time for interested persons
both to consider all the information
provided by the Agency related to the
workshop and to submit additional
comments.
DATES: Submit either electronic or
written comments by June 22, 2011.
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.
FOR FURTHER INFORMATION CONTACT:
Connie Jung, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3100,
connie.jung@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
I. Background
In the Federal Register of January 7,
2011 (76 FR 1182), FDA published a
notice announcing a public workshop
entitled ‘‘Determination of System
Attributes for the Tracking and Tracing
of Prescription Drugs; Public
Workshop.’’ In that notice, FDA
requested the following: (1) Input and
comments from interested stakeholders
regarding possible approaches to
developing a track-and-trace system and
(2) input from supply chain partners on
potential attributes and standards for
the identification, authentication, and
tracking and tracing of prescription drug
packages.
Interested persons were originally
given until April 16, 2011, to submit
comments.
II. Request for Comments
On April 4, 2011, FDA posted on the
FDA Web site a summary of the main
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
comments shared by the public
workshop participants. To allow
adequate time for interested persons
both to consider all the information
provided by the Agency related to the
workshop and to submit additional
comments, FDA is reopening the
comment period.
III. How to Submit 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: May 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12617 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 23, 2011, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910.
The hotel’s telephone number is 301–
589–5200.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, e-mail:
PO 00000
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PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On June 23, 2011, the
committee will discuss the new drug
application (NDA) 22150, icatibant
solution for injection (proposed trade
name Firazyr), Shire Human Genetic
Therapies, for the proposed indication
of treatment of acute attacks of
hereditary angioedema.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 16, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. to 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 8,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
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]]>Agencies
[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29765-29766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0633]
Determination of System Attributes for the Tracking and Tracing
of Prescription Drugs; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of the comment period.
-----------------------------------------------------------------------
[[Page 29766]]
SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the notice of public workshop published in the
Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA
announced a public workshop that took place on February 15 and 16,
2011, and requested public comment regarding the topics discussed at
the workshop on determining system attributes for tracking and tracing
prescription drugs. The workshop provided a forum for discussing
possible approaches to developing a track-and-trace system and for
obtaining input from supply chain partners on potential attributes and
standards for the identification, authentication, and tracking and
tracing of prescription drug packages. FDA is reopening the comment
period to allow additional time for interested persons both to consider
all the information provided by the Agency related to the workshop and
to submit additional comments.
DATES: Submit either electronic or written comments by June 22, 2011.
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.
FOR FURTHER INFORMATION CONTACT: Connie Jung, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100,
connie.jung@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 7, 2011 (76 FR 1182), FDA
published a notice announcing a public workshop entitled
``Determination of System Attributes for the Tracking and Tracing of
Prescription Drugs; Public Workshop.'' In that notice, FDA requested
the following: (1) Input and comments from interested stakeholders
regarding possible approaches to developing a track-and-trace system
and (2) input from supply chain partners on potential attributes and
standards for the identification, authentication, and tracking and
tracing of prescription drug packages.
Interested persons were originally given until April 16, 2011, to
submit comments.
II. Request for Comments
On April 4, 2011, FDA posted on the FDA Web site a summary of the
main comments shared by the public workshop participants. To allow
adequate time for interested persons both to consider all the
information provided by the Agency related to the workshop and to
submit additional comments, FDA is reopening the comment period.
III. How to Submit 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: May 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12617 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P
