[Federal Register: January 9, 2009 (Volume 74, Number 6)]
[Notices]
[Page 904-906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja09-41]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0500]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements on
Content and Format of Labeling for Human Prescription Drug and
Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 9, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:
[[Page 905]]
202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0572. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products (OMB Control Number 0910-0572)--Extension
FDA's final rule entitled ``Requirements on Content and Format of
Labeling for Human Prescription Drug and Biological Products'' (the
final rule), which published on January 24, 2006 (71 FR 3922), and was
effective on June 30, 2006, amended FDA's regulations governing the
format and content of labeling for human prescription drug and
biological products to require that the labeling of new and recently
approved products contain highlights of prescribing information, a
table of contents for prescribing information, reordering of certain
sections, minor content changes, and minimum graphical requirements.
These revisions were intended to make it easier for health care
practitioners to access, read, and use information in prescription drug
labeling, to enhance the safe and effective use of prescription drug
products, and reduce the number of adverse reactions resulting from
medication errors due to misunderstood or incorrectly applied drug
information.
A. Summary of Prescription Drug Labeling Content and Format
Requirements That Contain Collections of Information
Section 201.56 (21 CFR 201.56) requires that prescription drug
labeling contain certain information in the format specified in either
Sec. 201.57 (21 CFR 201.57) or Sec. 201.80 (21 CFR 201.80), depending
on when the drug was approved for marketing.
Section 201.56(a) sets forth general labeling requirements
applicable to all prescription drugs. Section 201.56(b) specifies the
categories of new and more recently approved prescription drugs subject
to the revised content and format requirements in Sec. Sec. 201.56(d)
and 201.57. Section 201.56(c) sets forth the schedule for implementing
these revised content and format requirements. Section 201.56(e)
specifies the sections and subsections, required and optional, for the
labeling of older prescription drugs not subject to the revised format
and content requirements.
Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include
``Highlights of Prescribing Information.'' Highlights provides a
concise extract of the most important information required under Sec.
201.57(c) (the Full Prescribing Information (FPI)), as well as certain
additional information important to prescribers. Section 201.57(b)
requires a table of contents to prescribing information, entitled
``Full Prescribing Information: Contents,'' consisting of a list of
each heading and subheading along with its identifying number to
facilitate health care practitioners' use of labeling information.
Section 201.57(c) specifies the contents of the FPI. Section 201.57(d)
mandates the minimum specifications for the format of prescription drug
labeling and establishes minimum requirements for key graphic elements
such as bold type, bullet points, type size, and spacing.
Older drugs not subject to the revised labeling content and format
requirements in Sec. 201.57 remain subject to labeling requirements at
Sec. 201.80 (in the final rule, former Sec. 201.57 was redesignated
as Sec. 201.80). Section 201.80(f)(2) requires that within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.
B. Estimates of Reporting Burden
The PRA information collection analysis in the final rule (71 FR
3922 at 3964 to 3967) (currently approved under OMB Control Number
0910-0572) estimated the reporting burden for a multi-year period. We
are requesting that OMB extend approval for the information in this
collection, as described below, which continue to be submitted to FDA
during this multi-year period.
Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec. 201.56 and 201.57) (Table 1)
New drug product applicants must: (1) Design and create
prescription drug labeling containing Highlights, Contents, and FPI,
(2) test the designed labeling (e.g., to ensure that the designed
labeling fits into carton-enclosed products), and (3) submit it to FDA
for approval. Based on the projected data estimated in the final rule,
FDA estimates that it takes applicants approximately 3,349 hours to
design, test, and submit prescription drug labeling to FDA as part of
an NDA or BLA under the revised regulations. Approximately 85
applicants submit approximately 107 new applications (NDAs and BLAs) to
FDA per year, totaling 358,343 hours.
Burden Associated with Labeling Supplements for Applications Approved
Within 5 Years Prior to the Effective Date of the Rule (Sec. 201.57)
(Table 2)
The final rule required that prescription drug applications
approved during the 5 years before, or pending on, the effective date
conform to format and content requirements at Sec. 201.57. For these
products, applicants must redesign and negotiate the labeling,
including Highlights and Contents, test the redesigned labeling, and
prepare and submit that labeling to FDA for approval. Based on the
projected data estimated in the final rule, labeling supplements for a
total of approximately 344 innovator products are expected to be
submitted to FDA over a 5-year period (beginning in year 3 and ending
in year 7 after the effective date of the final rule). Approximately
172 applicants submit these labeling supplements, and the time required
for redesigning, testing, and submitting the labeling to FDA is
approximately 196 hours per application, totaling 67,424 hours.
Burden Associated with Revised Labeling Efficacy Supplements Submitted
on or After the Effective Date of the Rule (Sec. Sec. 201.56(d) and
201.57) (Table 2)
Efficacy supplemental applications for older drugs submitted to FDA
on or after the effective date of the final rule are subject to the
content and format requirements of Sec. Sec. 201.56(d) and 201.57. To
meet these requirements, applicants must revise the existing labeling
for these products. Each year an increasing number of innovator drug
labeling will have been revised, and over time, very few efficacy
supplements independently will generate labeling revisions. Based on
the projected data estimated in the final rule, the number of affected
efficacy supplements over 10 years, beginning with year 3, is 186, with
a decreasing number each year over the period. Approximately 172
applicants will
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trigger approximately 186 efficacy supplements, each one requiring
approximately 196 hours to revise the labeling in the application,
totaling 36,456 hours. (As stated in the final rule, in addition to
this burden, a minimal annual reporting burden (fewer than 7) will
continue indefinitely).
Burden Associated with Revised Labeling for Efficacy Supplements for
Generic Drug Products (Sec. 201.57) (Table 2)
Based on the projected data estimated in the final rule, beginning
in year 3 and continuing throughout the 10-year period analyzed,
approximately 42 generic applicants per year must submit labeling
supplements. Approximately 336 already approved generic drug
applications must submit labeling supplements over the 10-year period
after the effective date of the rule. The time required to revise and
submit this labeling to FDA is approximately 27 hours per application,
totaling 9,072 hours. (As stated in the final rule, in addition to this
burden, a minimal annual reporting burden associated with a very small
number of generic applications referencing older drugs may continue
indefinitely).
C. Capital Costs
As discussed in the final rule, a small number of carton-enclosed
products may require new packaging to accommodate longer inserts. As
many as 5 percent of the existing products affected by the final rule
(i.e., products with new efficacy supplements, products approved in the
5 years prior to the effective date of the rule, and affected
abbreviated new drug applications) may require equipment changes at an
estimated cost of $200,000 each product.
In the Federal Register of September 29, 2008 (73 FR 56592), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received relating to the
paperwork.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden For New Drug Applications\1\
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Category (21 CFR No. of Responses per Hours per
Section) No. of Respondents Respondent Total Responses Response Total Hours
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Annual Burden for 85 1.26 107 3,349 358,343
Labeling
Requirements in
Sec. Sec.
201.56 and 201.57
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Total .................... .................... .................. ............... 358,343
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Reporting Burdens For Labeling Revisions To Already-Approved Drug Products\1\
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Category (21 CFR No. of Responses per Hours per
Section) No. of Respondents Respondent Total Responses Response Total Hours
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Burden associated 172 2 344 196 67,424
with revised
labeling for
applications
approved within 5
years prior to
June 30, 2006
(Sec. 201.57)
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Burden associated 172 1.08 186 196 36,456
with revised
labeling for
efficacy
supplements
submitted on or
after June 30,
2006 (Sec. Sec.
201.56(d) and
201.57)
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Burden associated 42 8 336 27 9,072
with revised
labeling for
efficacy
supplements for
generic drug
products (Sec.
201.57)
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Total .................... .................... .................. ............... 112,952
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-175 Filed 1-8-09; 8:45 am]
BILLING CODE 4160-01-S