Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Event Program for Medical Devices (Medical Product Safety Network), 34758-34759 [2014-14252]
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Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
information. Six comment submissions
were received, some of which included
multiple comments.
(Comment) Regarding the clarity of
information collected, several comments
indicated some confusion between the
information being collected and the
information needed to support an
exemption request.
(Response) Section 1107.1(a) sets out
the general requirements for requesting
an exemption, but a manufacturer will
need to determine how to meet the
requirements for any of its new products
that use the pathway. FDA intends to
consider issuing a regulation or
guidance to further clarify terms as
experience is gained with the pathway.
(Comment) A few comments
questioned the quality of the
information being requested.
(Response) We disagree that the
information required in an exemption
request is not sufficient. We believe the
information requested is what FDA
needs to make a determination on an
exemption request. Furthermore, several
commenters also agreed with the
sufficiency of the information needed to
support an exemption request.
(Comment) Many comments
addressed the accuracy of FDA’s
estimate of the burden for requesting a
modification to an exemption request
and questioned whether this burden
was underestimated. Additionally, there
was reference to the submittal of
duplicative information.
(Response) FDA disagrees with these
comments. We believe the burden
estimates are appropriate and reflect the
information needed by FDA when
reviewing an exemption request. FDA
also disagrees that there is duplicative
information requested. The regulations
implement the requirements of the
FD&C Act for the exemption pathway to
market. The commenters may be
referring to the other notification and
reporting requirements related to
additives, such as those in section
904(c) of the FD&C Act (21 U.S. C.
387d(c)), but those requirements are not
in the scope of this information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
21 CFR 1107.1(b): Preparation of tobacco product exemption from substantial equivalence request .......................
21 CFR 1107.1(c): Preparation of additional information
for tobacco product exemption from substantial equivalence request ....................................................................
21 CFR 25.40: Preparation of an environmental assessment ..................................................................................
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption
granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are
to a product that is commercially marketed and compliant product, and modifications covered by exemptions
granted by Secretary pursuant to section 905(j)(3) .........
Total ..............................................................................
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1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
500
1
500
12
6,000
150
1
150
3
450
500
1
500
12
6,000
750
1
750
3
2,250
........................
........................
........................
........................
14,700
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 500 requests for
exemption will be submitted annually,
and that it will take approximately 12
hours to prepare an exemption request.
FDA also estimates that up to 30 percent
(150) of the initial requests for
information may require additional
information in support of the initial
exemption request, and it is expected
that it will take an average of 3 hours
to prepare the additional information.
FDA also estimates that 750
manufacturers will take approximately
12 hours to prepare and submit an EA
under part 25 in accordance with the
requirements of § 25.40, as referenced in
§ 1107.1(b)(9).
FDA estimates that 750 respondents
will take 3 hours to prepare a report
under section 905(j)(1)(A)(ii) of the
FD&C Act, which requires a
manufacturer to submit a report at least
90 days prior to making an introduction
or delivery into interstate commerce for
commercial distribution of a tobacco
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product. The report will contain the
manufacturer’s basis that the tobacco
product is modified within the meaning
of section 905(j)(3) of the FD&C Act, the
modifications are to a product that is
commercially marketed and compliant
with the FD&C Act, the modifications
are covered by exemptions granted
pursuant to section 905(j)(3), and a
listing of actions taken to comply with
any applicable requirements of section
907 of the FD&C Act (21 U.S.C. 387g).
FDA’s estimates are based on experience
with and information on other FDAregulated products and indications from
industry.
Dated: June 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14253 Filed 6–17–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1439]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Adverse Event Program for Medical
Devices (Medical Product Safety
Network)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Adverse Event Program for Medical
Devices (Medical Product Safety
Network (MedSun))’’ has been approved
by the Office of Management and
SUMMARY:
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Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
Budget (OMB) under the Paperwork
Reduction Act of 1995.
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: On April
22, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Adverse Event Program for
Medical Devices (Medical Product
Safety Network (MedSun))’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0471. The approval expires on
May 31, 2017. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14252 Filed 6–17–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0397]
Draft Guidance for Industry on
Internet/Social Media Platforms With
Character Space Limitations:
Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Internet/
Social Media Platforms with Character
Space Limitations: Presenting Risk and
Benefit Information for Prescription
Drugs and Medical Devices.’’ This draft
guidance responds to, among other
things, stakeholder requests for specific
guidance and describes FDA’s current
thinking on how manufacturers,
packers, and distributors (firms) of
prescription human and animal drugs
(drugs) and medical devices for human
use (devices), including biological
products, that choose to present benefit
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SUMMARY:
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information should present both benefit
and risk information within advertising
and promotional labeling of their FDAregulated medical products on
electronic/digital platforms that are
associated with character space
limitations, specifically on the Internet
and through social media or other
technological venues (Internet/social
media). The draft guidance represents
FDA’s current thinking on specific
aspects of FDA’s evolving consideration
of social media platforms and other
Internet-related matters. FDA continues
actively to review, analyze, and develop
approaches to a variety of topics related
to the labeling and advertising of
medical products, including the
development of this and other guidance
addressing the use of social media
platforms and the Internet.
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 comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 16,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002; or to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
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.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs:
Jean-Ah Kang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993, 301–796–1200.
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34759
Regarding prescription human
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
Regarding animal prescription drugs:
Dorothy McAdams, Center for
Veterinary Medicine (HFV–216), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9300.
Regarding medical devices for human
use: Deborah Wolf, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993,
301–796–5732.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Internet/Social Media Platforms with
Character Space Limitations: Presenting
Risk and Benefit Information for
Prescription Drugs and Medical
Devices.’’
On November 12 and 13, 2009, FDA
held a public hearing entitled
‘‘Promotion of Food and Drug
Administration—Regulated Medical
Products Using the Internet and Social
Media Tools’’ to provide an opportunity
for broad public participation and
comment on the following questions
that relate specifically to promotional
issues:
1. For what online communications
are manufacturers, packers, or
distributors accountable?
2. How can manufacturers, packers, or
distributors fulfill regulatory
requirements (e.g., fair balance,
disclosure of indication and risk
information, and postmarketing
submission requirements) in their
internet and social media promotion,
particularly when using tools that are
associated with space limitations and
tools that allow for real-time
communications (e.g., microblogs and
mobile technology)?
3. What parameters should apply to
the posting of corrective information on
Web sites controlled by third parties?
4. When is the use of links
appropriate?
Subsequent to the live testimony
heard at the public hearing, FDA
received 72 comments to the docket.
Specifically, this draft guidance
presents considerations to illustrate
FDA’s thinking on factors that are
relevant to the communication of
benefit and risk information on Internet/
social media platforms with character
space limitations. Examples of Internet/
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]]>Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34758-34759]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1439]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Adverse Event Program for Medical
Devices (Medical Product Safety Network)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Adverse Event Program for Medical
Devices (Medical Product Safety Network (MedSun))'' has been approved
by the Office of Management and
[[Page 34759]]
Budget (OMB) under the Paperwork Reduction Act of 1995.
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: On April 22, 2014, the Agency submitted a
proposed collection of information entitled ``Adverse Event Program for
Medical Devices (Medical Product Safety Network (MedSun))'' to OMB for
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0471. The approval expires on May 31, 2017. A copy
of the supporting statement for this information collection is
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14252 Filed 6-17-14; 8:45 am]
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