[Federal Register: September 7, 2005 (Volume 70, Number 172)]
[Notices]
[Page 53233-53235]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se05-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0334]
Draft Guidance for Industry on the Pediatric Research Equity Act;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availability of a draft guidance for industry entitled ``How to Comply
with the Pediatric Research Equity Act.'' This draft guidance provides
recommendations on how to interpret the requirements of the Pediatric
Research Equity Act (PREA), which requires pediatric studies of certain
drugs and biological products to ensure that those products that are
likely to be commonly used in children or that represent a meaningful
therapeutic benefit over existing treatments contain adequate pediatric
labeling for approved indications.
DATES: Submit written or electronic comments on the draft guidance by
November 7, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857; or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug Evaluation and Research (HFD-950),
Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857,
301-594-2041, or
Leonard Wilson, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1401 Rockville Pike, suite 200N
Rockville, MD 20852-1448, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``How to Comply with the Pediatric Research Equity Act.'' On
December 3, 2003, the Pediatric Research Equity Act was signed into
law. PREA amends the Federal Food, Drug, and Cosmetic Act (the act) by
adding section 505B (21 U.S.C. 355B). In PREA, Congress codified many
of the elements of the Pediatric Rule, a final rule issued by FDA on
December 2, 1998 (63 FR 66632), and suspended by court order on October
17, 2002. Association of American Physicians, and Surgeons, Inc. v.
FDA, 226 F. Supp. 2d 204 (D.D.C. 2002). Specifically, PREA, in adding
section 505B(a) of the act, requires all applications (or supplements
to an application) submitted under section 505 of the act (21 U.S.C.
355) or section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262) for a new active ingredient, new indication, new dosage
form, new dosing regimen, or
[[Page 53234]]
new route of administration to contain a pediatric assessment unless
the applicant has obtained a waiver or deferral. PREA also authorizes
FDA, under section 505B(b) of the act, to require holders of previously
approved applications for marketed drugs and biological products to
conduct pediatric studies under certain circumstances, even if the
holders are not seeking one of the changes listed under section 505B(a)
of the act. This draft guidance only provides recommendations related
to studies required under section 505B(a) of the act.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 how to comply with PREA. 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) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance and received
comments are available for public examination 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 (44 U.S.C. 3501-3520) (the PRA),
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 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 comment on: (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 on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Title: Draft Guidance for Industry: How to Comply with the
Pediatric Research Equity Act.
Description: The draft guidance provides recommendations to
sponsors on how to interpret the requirements of PREA. PREA requires
new drug applications (NDAs) and biologics licensing applications
(BLAs) (or supplements to an applications) for a new active ingredient,
new indication, new dosage form, new dosing regimen, or new route of
administration to contain a pediatric assessment unless the applicant
has obtained a waiver or deferral. Although PREA applies to both new
applications (or supplements to an application) and currently marketed
drugs and biological products for which a sponsor is not seeking one of
the enumerated changes, the guidance only provides recommendations
related to new applications or supplements to applications for drugs
and biological products.
Description of Respondents: Sponsors of NDAs or BLAs for human
drugs and biological products.
Burden Estimate: FDA is requesting public comments on estimates of
annual submissions expected in 2005 (based on the number of submissions
received in 2003 and 2004 unless otherwise indicated) as required by
the following PREA requirements described in the draft guidance:
Section 505B(a)(1) and (a)(2)--The draft guidance provides
recommendations for submitting pediatric studies with applications (or
supplements to an application) for a new active ingredient, new
indication, new dosage form, new dosing regimen, or new route of
administration under section 505 of the act or section 351 of the PHS
Act. These assessments are required to contain data that are adequate
to assess the safety and effectiveness of the drug product for the
claimed indications in the relevant pediatric subpopulations and to
support dosing and administration for each subpopulation for which the
product is safe and effective. FDA estimates that 106 pediatric use
assessments will be submitted from 78 applicants and it will take 50
hours to prepare each assessment.
Section 505B(a)(3)--The draft guidance makes recommendations on how
to request a deferral of some or all assessments of safety and
effectiveness required under PREA. FDA estimates that it will receive
160 requests to defer assessments from 54 applicants and it will take
24 hours to prepare each request.
Section 505B(a)(4)--The draft guidance provides recommendations on
how to request a full or partial waiver of the pediatric study
requirements. Based on its 2003 and 2004 experience, FDA anticipates
that it will receive approximately 110 requests annually from
approximately 80 applicants and estimates it will take approximately 8
hours to prepare each request.
Section 505B(e)--The draft guidance makes recommendations for
applicants to meet at appropriate times with FDA to discuss plans and
timelines for pediatric studies and any planned requests for deferral
or waiver of pediatric studies. FDA estimates it will receive 160
submissions associated with meetings to discuss pediatric plans from 95
applicants at 16 hours per meeting submission.
FDA estimates that the collection of information resulting from
this draft guidance is as follows:
Table 1.--Estimated Annual Reporting Burden
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PREA Number of Responses Total Annual Hours per
Provision Number of Respondents per Respondent Responses Response Total Hours
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505B(a)(1) 78 1.4 106 50 5,300
and (a)(2)
Submission
of pediatric
assessments
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[[Page 53235]]
505B(a)(3) 54 3.0 160 24 3,840
Deferrals
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505B(a)(4) 80 1.4 110 8 880
Full and
partial
waivers
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505B(e) 95 1.7 160 16 2,560
Meetings
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Total ....................... ....................... .............. ............ 12,580
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In addition, the draft guidance discusses when sponsors may need to
report on the status of postmarketing study commitments as part of
annual reports submitted under 21 CFR 314.81(b) and 21 CFR 601.70. The
burdens associated with the annual reporting requirements were
previously accounted for under OMB number 0910-0001 (expires 5/31/08)
(for 21 CFR 314.81(b) and OMB number 0910-0433 (expires 3/31/07) (for
21 CFR 601.70). Furthermore, although labeling submissions are required
under certain PREA provisions (e.g., section 505B(a)(4)(D) of the act),
the draft guidance does not provide recommendations on these
requirements and therefore FDA has not estimated associated burdens.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ets/default.htm.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17694 Filed 9-6-05; 8:45 am]
BILLING CODE 4160-01-S