[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20686-20688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8895]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0164]
Draft Guidance for Industry on Safety Labeling Changes;
Implementation of the Federal Food, Drug, and Cosmetic Act;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Safety
Labeling Changes--Implementation of Section 505(o)(4) of the Federal
Food, Drug, and Cosmetic Act.'' The Food and Drug Administration
Amendments Act of 2007 (FDAAA) added new provisions to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require
certain drug and biological product application holders to make safety
related labeling changes based upon new safety information that becomes
available after the drug or biological product is approved under the
FD&C Act or the Public Health Service Act (the PHS Act). This draft
guidance provides information on the implementation of the new
provisions, including a description of the types of safety labeling
changes that ordinarily might be required under the new legislation,
how FDA plans to determine what constitutes new safety information, the
procedures involved in requiring safety labeling changes, and
enforcement of the requirements for safety labeling changes.
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 comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 12, 2011.
ADDRESSES: Submit written requests for single copies of this 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 the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.
Send one self-addressed adhesive label to assist the office in
processing your requests. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Kristen Everett, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-5400, or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Safety Labeling Changes--Implementation of Section 505(o)(4)
of the Federal Food, Drug, and Cosmetic Act.'' In the past, FDA has
requested that holders of applications for approved products make
labeling changes related to safety after approval to address serious
risks. FDA learned of the potential for such serious risks from a
variety of sources. In most cases, application holders responded to
these requests by negotiating appropriate language with FDA staff to
address the concerns, and then submitting a supplement or amended
supplement to obtain approval of the change. Negotiations were often
protracted, and FDA had few tools available at its disposal to end
negotiations and require the changes. Congress recognized the
limitations of FDA's authority in this area and, in FDAAA, gave FDA new
authority to require safety labeling changes in certain circumstances.
Title IX, section 901 of FDAAA (Pub. L. 110-85) amended the FD&C
Act by adding new section 505(o)(4) (21 U.S.C. 355(o)(4)). Section
505(o)(4) authorizes FDA to require, and if necessary, order labeling
changes if FDA becomes aware of new safety information that FDA
believes should be included in the labeling of certain prescription
drug and biological products approved under section 505 of the FD&C Act
or section 351 of the PHS Act (42 U.S.C. 262). Specifically, section
505(o)(4) of the FD&C Act applies to prescription drug products with an
approved new drug application (NDA) under section 505(b) of the FD&C
Act, biological products with an approved biologics license application
(BLA) under section 351 of the PHS Act, or prescription drug products
with an approved abbreviated new drug application (ANDA) under section
505(j) of the FD&C Act if the reference listed drug (RLD) with an
approved NDA is not currently marketed. FDAAA imposes timeframes for
application holders to submit and FDA staff to review such changes, and
gives FDA new enforcement tools to bring about timely and appropriate
labeling changes. This draft guidance provides information on the
implementation of the new provisions, including a description of the
types of safety labeling changes that ordinarily
[[Page 20687]]
might be required under the new legislation, how FDA plans to determine
what constitutes new safety information, the procedures involved in
requiring safety labeling changes, and enforcement of the requirements
for safety labeling changes.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the
implementation of section 901 of FDAAA on safety labeling changes. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
II. 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.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collections of information associated with this
draft guidance that were not previously approved by OMB, described
below, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
This draft guidance provides information on the implementation of
section 901 of FDAAA, which authorizes FDA to require certain drug and
biological product application holders to make safety related labeling
changes based upon new safety information that becomes available after
the drug or biological product is approved under the FD&C Act or the
PHS Act. FDA plans to request safety labeling changes by sending a
notification letter to the application holder. Under section
505(o)(4)(B), the application holder must respond to FDA's notification
by submitting a labeling supplement or notifying FDA that the applicant
does not believe the labeling change is warranted and submitting a
statement detailing the reasons why the application holder does not
believe a change is warranted (a rebuttal statement).
The submission of rebuttal statements may result in the collection
of information that is not already approved by OMB. Based on FDA's
experience thus far with safety labeling changes requirements under
section 505(o)(4), FDA estimates that approximately six application
holders will elect to submit approximately one rebuttal statement each
year and that each rebuttal statement will take approximately 6 hours
to prepare.
In addition, in the draft guidance, the agency states that new
labeling prepared in response to a safety labeling change notification
should be available on the application holder's Web site within 10
calendar days of approval, which may result in the collection of
information that is not already approved by OMB. FDA estimates that
approximately 197 application holders will post new labeling one time
each year in response to a safety labeling change notification and that
the posting of the labeling will take approximately 4 hours to prepare.
FDA estimates the burden of the collections of information that
have not already been approved by OMB, is as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of responses per Total Hours per Total hours
respondents respondent responses response
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Rebuttal statement................................................. 6 1 6 6 36
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Total.......................................................... ............... ............... ............... ............... 36
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Table 2--Estimated Annual Third Party Disclosure Burden \1\
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Annual
Type of submission Number of frequency per Total annual Hours per Total hours
respondents disclosure disclosures disclosure
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Post approved labeling on application holder's Web site............ 197 1 197 4 788
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
This draft guidance also refers to previously approved collections
of information. Specifically, the draft guidance describes: Labeling
supplements for NDAs, ANDAs, and BLAs submitted under 21 CFR 314.70,
[[Page 20688]]
314.71, 314.97 and 601.12; and the content and format of prescription
drug labeling submitted under 21 CFR 201.56 and 201.57. These
collections of information are subject to review by OMB under the PRA
act and are approved under OMB control numbers 0910-0001, 0910-0338,
and 0910-0572. Section V of the draft guidance refers to the guidance
entitled ``Formal Dispute Resolution: Appeals Above the Division
Level,'' which describes collections of information approved under OMB
control number 0910-0430.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8895 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P