Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, 74062-74063 [2010-30036]
Download as PDF
<![CDATA[
74062
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
Annually, FDA projects about 20
focus group studies using 160 focus
groups with an average of 9 persons per
group, and lasting an average of 1.75
hours each. FDA is requesting this
burden for unplanned focus groups so
as not to restrict the Agency’s ability to
gather information on public sentiment
of its proposals in its regulatory and
communications programs.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30037 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exceptions or
Alternatives to Labeling Requirements
for Products Held by the Strategic
National Stockpile
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 information collection requirements
for FDA regulations related to the
exceptions or alternatives to labeling
requirements for products held by the
Strategic National Stockpile (SNS).
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 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.
jdjones on DSK8KYBLC1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:13 Nov 29, 2010
Jkt 223001
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@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 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.
SUPPLEMENTARY INFORMATION:
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile—(OMB
Control Number 0910–0614)—Extension
Under the Public Health Service Act
(the PHS Act), the Department of Health
and Human Services stockpiles medical
products that are essential to the health
security of the Nation (see section 319F–
2 of the PHS Act (42 U.S.C. 247d-6b)).
This collection of medical products for
use during national health emergencies,
known as the SNS, is to ‘‘provide for the
emergency health security of the United
States, including the emergency health
security of children and other
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
vulnerable populations, in the event of
a bioterrorist attack or other public
health emergency.’’
It may be appropriate for certain
medical products that are or will be
held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352).
In the Federal Register of December
28, 2007 (72 FR 73589), FDA published
an interim final rule entitled
‘‘Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile.’’ In the
interim final rule, FDA issued
regulations under §§ 201.26, 610.68,
801.128, and 809.11 (21 CFR 201.26,
610.68, 801.128, and 809.11), which
allow the appropriate FDA Center
Director to grant a request for an
exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, medical devices, and in vitro
diagnostics that currently are or will be
included in the SNS if certain criteria
are met. The appropriate FDA Center
Director may grant an exception or
alternative to certain FDA labeling
requirements if compliance with these
labeling requirements could adversely
affect the safety, effectiveness, or
availability of products that are or will
be included in the SNS. An exception
or alternative granted under the
regulations may include conditions or
safeguards so that the labeling for such
products includes appropriate
information necessary for the safe and
effective use of the product given the
product’s anticipated circumstances of
use. Any grant of an exception or
alternative will only apply to the
specified lots, batches, or other units of
medical products in the request. The
appropriate FDA Center Director may
also grant an exception or alternative to
the labeling provisions specified in the
regulations on his or her own initiative.
Under § 201.26(b)(1)(i) (human drug
products), § 610.68(b)(1)(i) (biological
products), § 801.128(b)(1)(i) (medical
devices), and § 809.11(b)(1)(i) (in vitro
diagnostic products for human use) an
SNS official or any entity that
manufactures (including labeling,
packing, relabeling, or repackaging),
distributes, or stores such products that
are or will be included in the SNS may
submit, with written concurrence from
a SNS official, a written request for an
exception or alternative to certain
labeling requirements to the appropriate
E:\FR\FM\30NON1.SGM
30NON1
74063
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
FDA Center Director. Except when
initiated by an FDA Center Director, a
request for an exception or alternative
must be in writing and must:
• Identify the specified lots, batches,
or other units of the affected product;
• Identify the specific labeling
provisions under this rule that are the
subject of the request;
• Explain why compliance with the
specified labeling provisions could
adversely affect the safety, effectiveness,
or availability of the product subject to
the request;
• Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the product
includes appropriate information
necessary for the safe and effective use
of the product given the anticipated
circumstances of use of the product;
• Provide copies of the proposed
labeling of the specified lots, batches, or
other units of the affected product that
will be subject to the exception or
alternative; and
• Provide any other information
requested by the FDA Center Director in
support of the request.
If the request is granted, the
manufacturer may need to report to FDA
any resulting changes to the New Drug
Application, Biologics License
Application, Premarket Approval
Application or Premarket Notification
(510(k)) in effect, if any. The submission
and grant of an exception or an
alternative to the labeling requirements
specified in the interim final rule (72 FR
73589) may be used to satisfy certain
reporting obligations relating to changes
to product applications under § 314.70
(21 CFR 314.70) (human drugs), § 601.12
(21 CFR 601.12) (biological products),
§ 814.39 (21 CFR 814.39) (medical
devices subject to premarket approval),
or § 807.81 (21 CFR 807.81) (medical
devices subject to 510(k) clearance
requirements). The information
collection provisions in §§ 314.70,
601.12, 807.81, and 814.39 have been
approved under OMB control numbers
0910–0001, 0910–0338, 0910–0120, and
0910–0231, respectively. On a case-bycase basis, the appropriate FDA Center
Director may also determine when an
exception or alternative is granted that
certain safeguards and conditions are
appropriate, such as additional labeling
on the SNS products, so that the
labeling of such products would include
information needed for safe and
effective use under the anticipated
circumstances of use.
Respondents to this collection of
information are entities that
manufacture (including labeling,
packing, relabeling, or repackaging),
distribute or store affected SNS
products. Based on the number of
requests for an exception or alternative
received by FDA since issuance of the
interim final rule, FDA estimates an
average of two requests annually. FDA
is estimating that each respondent will
spend an average of 24 hours preparing
each request. The hours per response for
each submission are based on the
estimated time that it takes to prepare a
supplement to an application, which
may be considered similar to a request
for an exception or alternative. To the
extent that labeling changes not already
required by FDA regulations are made
in connection with an exception or
alternative granted under the interim
final rule, FDA is estimating one
occurrence annually in the event FDA
would require any additional labeling
changes not already covered by FDA
regulations, and that it would take 8
hours to develop and revise the labeling
to make such changes.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per response
Number of
respondents
21 CFR section
Total annual
responses
Hours per
response
Total hours
201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and
809.11(b)(1)(i) ...................................................................
201.26(b)(1)(i), 610.68(b)(1)(i), ............................................
801.128(b)(1)(i), and 809.11(b)(1)(i) ....................................
2
1
2
24
48
1
1
1
8
8
Total ..............................................................................
........................
........................
........................
........................
56
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jdjones on DSK8KYBLC1PROD with NOTICES
[Docket No. FDA–2010–N–0576]
Supplemental Funding Under the Food
and Drug Administration’s Convener of
Active Medical Product Surveillance
Discussions (U13) RFA–FD–09–012;
Request for Supplemental Application
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
15:13 Nov 29, 2010
Jkt 223001
The Food and Drug
Administration (FDA) is announcing a
program expansion of its Conference
Cooperative Agreement Program (U13),
awarded to the Engelberg Center for
Health Care Reform at the Brookings
Institution (Brookings). The goal of this
expansion is to plan and hold meetings
and conferences that will ensure broad
stakeholder input on FDA programs and
initiatives related to disseminating
information from active medical
product surveillance activities and other
sources of product information.
SUMMARY:
[FR Doc. 2010–30036 Filed 11–29–10; 8:45 am]
AGENCY:
Notice of intent.
Important dates are as follows:
1. The supplemental application due
date is December 13, 2010.
2. The award anticipated start date is
January 1, 2011.
DATES:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
3. The opening date is November 30,
2010.
4. The expiration date is December 14,
2010.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
Melissa Robb, Office of Medical Policy,
Food and Drug Administration, 10903
New Hampshire Ave, Bldg. 51, rm.
6360, Silver Spring, MD 20993–0002,
301–796–2500, e-mail:
Melissa.Robb@fda.hhs.gov; or
Camille R. Peake, Division of
Acquisition Support and Grants, Food
and Drug Administration, 5630
Fishers Lane (HFA–500), Rockville,
MD 20857, 301–827–7175, FAX: 301–
827–7101, e-mail:
Camille.Peake@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Notices]
[Pages 74062-74063]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30036]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0588]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exceptions or Alternatives to Labeling Requirements
for Products Held by the Strategic National Stockpile
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
requirements for FDA regulations related to the exceptions or
alternatives to labeling requirements for products held by the
Strategic National Stockpile (SNS).
DATES: Submit either electronic or written comments on the collection
of information by January 31, 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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@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.
Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile--(OMB Control Number 0910-0614)--
Extension
Under the Public Health Service Act (the PHS Act), the Department
of Health and Human Services stockpiles medical products that are
essential to the health security of the Nation (see section 319F-2 of
the PHS Act (42 U.S.C. 247d-6b)). This collection of medical products
for use during national health emergencies, known as the SNS, is to
``provide for the emergency health security of the United States,
including the emergency health security of children and other
vulnerable populations, in the event of a bioterrorist attack or other
public health emergency.''
It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
In the Federal Register of December 28, 2007 (72 FR 73589), FDA
published an interim final rule entitled ``Exceptions or Alternatives
to Labeling Requirements for Products Held by the Strategic National
Stockpile.'' In the interim final rule, FDA issued regulations under
Sec. Sec. 201.26, 610.68, 801.128, and 809.11 (21 CFR 201.26, 610.68,
801.128, and 809.11), which allow the appropriate FDA Center Director
to grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the regulations
may include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
Under Sec. 201.26(b)(1)(i) (human drug products), Sec.
610.68(b)(1)(i) (biological products), Sec. 801.128(b)(1)(i) (medical
devices), and Sec. 809.11(b)(1)(i) (in vitro diagnostic products for
human use) an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate
[[Page 74063]]
FDA Center Director. Except when initiated by an FDA Center Director, a
request for an exception or alternative must be in writing and must:
Identify the specified lots, batches, or other units of
the affected product;
Identify the specific labeling provisions under this rule
that are the subject of the request;
Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
Provide any other information requested by the FDA Center
Director in support of the request.
If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the New Drug Application, Biologics
License Application, Premarket Approval Application or Premarket
Notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the interim final rule (72 FR 73589) may be used to satisfy certain
reporting obligations relating to changes to product applications under
Sec. 314.70 (21 CFR 314.70) (human drugs), Sec. 601.12 (21 CFR
601.12) (biological products), Sec. 814.39 (21 CFR 814.39) (medical
devices subject to premarket approval), or Sec. 807.81 (21 CFR 807.81)
(medical devices subject to 510(k) clearance requirements). The
information collection provisions in Sec. Sec. 314.70, 601.12, 807.81,
and 814.39 have been approved under OMB control numbers 0910-0001,
0910-0338, 0910-0120, and 0910-0231, respectively. On a case-by-case
basis, the appropriate FDA Center Director may also determine when an
exception or alternative is granted that certain safeguards and
conditions are appropriate, such as additional labeling on the SNS
products, so that the labeling of such products would include
information needed for safe and effective use under the anticipated
circumstances of use.
Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute or store affected SNS products. Based on the number of
requests for an exception or alternative received by FDA since issuance
of the interim final rule, FDA estimates an average of two requests
annually. FDA is estimating that each respondent will spend an average
of 24 hours preparing each request. The hours per response for each
submission are based on the estimated time that it takes to prepare a
supplement to an application, which may be considered similar to a
request for an exception or alternative. To the extent that labeling
changes not already required by FDA regulations are made in connection
with an exception or alternative granted under the interim final rule,
FDA is estimating one occurrence annually in the event FDA would
require any additional labeling changes not already covered by FDA
regulations, and that it would take 8 hours to develop and revise the
labeling to make such changes.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i), 2 1 2 24 48
610.68(b)(1)(i),
801.128(b)(1)(i), and
809.11(b)(1)(i)................
201.26(b)(1)(i), 1 1 1 8 8
610.68(b)(1)(i),...............
801.128(b)(1)(i), and
809.11(b)(1)(i)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 56
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30036 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
