[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 904-906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-175]


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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:

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202-395-6974, or e-mailed to [email protected]. 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\
----------------------------------------------------------------------------------------------------------------
 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\
----------------------------------------------------------------------------------------------------------------
 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