[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15752-15753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0104]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Requirements for Submission of Labeling for Human 
Prescription Drugs and Biologics in Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reporting requirements 
contained in the requirements for submission of labeling for human 
prescription drugs and biologics in electronic format.

DATES: Submit written or electronic comments on the collection of 
information by May 30, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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.

Requirements for Submission of Labeling for Human Prescription Drugs 
and Biologics in Electronic Format (OMB Control Number 0910-0530)--
Extension

    FDA is requesting that OMB extend approval under the PRA for the 
information collection contained in the final rule entitled 
``Requirements for Submission of Labeling for Human Prescription Drugs 
and Biologics in Electronic Format'' (68 FR 69009, December 11, 2003) 
(the final rule). The final rule amended FDA regulations governing the 
format in which certain labeling is required to be submitted for FDA 
review with new drug applications (NDAs), certain biological license 
applications (BLAs), abbreviated new drug applications (ANDAs), 
supplements, and annual reports. The final rule required that the 
content of labeling for prescription drug and biological products 
required under 21 CFR 201.100(d)(3) be submitted to FDA electronically 
in a form that FDA can process, review, and archive. Copies of product 
labeling have been required to be submitted to FDA for review in NDAs, 
certain BLAs, ANDAs, certain supplements, and annual reports under 
Sec. Sec.  314.50, 314.70, 314.81, 314.94, 314.97, 314.98, 601.2, and 
601.12 (21 CFR 314.50, 314.70, 314.81, 314.94, 314.97, 314.98, 601.2, 
and 601.12). Under these regulations, copies of labeling may be 
submitted electronically or on paper. The final rule added the 
requirement to submit the content of labeling in electronic format to 
simplify the drug labeling review process and speed up the approval of 
labeling changes.
    The reporting burden for submitting labeling under Sec. Sec.  
314.50, 314.70, 314.81, 314.94, 314.97, and 314.98 has been estimated 
by FDA and the collection of information has been approved by OMB under 
OMB control number 0910-0001, most recently until May 31, 2008. The 
reporting burden associated with current Sec. Sec.  601.2 and 601.12 
has also been estimated and that collection of information has been 
approved by OMB under OMB control number 0910-0338, most recently until 
September 30, 2008. We are not re-estimating these approved burdens in 
this action. Only the additional reoccurring reporting burdens 
associated with the electronic submission of the content of labeling in 
the final rule are estimated in this action.

[[Page 15753]]

    New NDAs (Sec.  314.50), ANDAs (Sec.  314.94), and BLAs (Sec.  
601.2): Based on the number of submissions during 2005 under the 
approved collections of information for Sec. Sec.  314.50, 314.94, and 
601.2, we estimate that approximately 75 NDA applicants, 160 ANDA 
applicants, and 6 BLA applicants (respondents) submit applications to 
us annually. We estimate that these applicants (respondents) submit 
approximately 111 NDAs, 766 ANDAs, and 21 BLAs each year that are 
subject to the requirements of the final rule. As explained in section 
V of the final rule, we estimate that the hours per response, i.e., the 
additional time necessary for submission of the content of labeling in 
electronic format for these applications, will be less than 15 minutes.
    Supplements to NDAs (Sec.  314.70), ANDAs (Sec.  314.97), and BLAs 
(Sec.  601.12(f)(1) and (f)(2)): Based on the number of submissions 
during 2005 under the approved collections of information for 
Sec. Sec.  314.70, 314.97, and Sec.  601.12(f)(1) and (f)(2), we 
estimate that approximately 272 NDA applicants, 189 ANDA applicants, 
and 35 BLA applicants (respondents) submit supplements to approved 
applications to us annually. We estimate that these applicants 
(respondents) submit approximately 1,839 NDA supplements, 3,208 ANDA 
supplements, and 82 BLA supplements each year that are subject to the 
requirements of the final rule. As explained in section V of the final 
rule, we estimate that the hours per response, i.e., the additional 
time necessary for submission of the content of labeling in electronic 
format for these applications, will be less than 15 minutes.
    Annual Reports for NDAs (Sec.  314.81), ANDAs (Sec.  314.98), and 
BLAs (Sec.  601.12(f)(3)): Based on the number of submissions during 
2005 under the approved collections of information for Sec. Sec.  
314.81, 314.98, and 601.12(f)(3), we estimate that approximately 306 
NDA applicants, 333 ANDA applicants, and 4 BLA applicants (respondents) 
submit annual reports to us annually. We estimate that NDA applicants 
submit to us approximately 2,617 annual reports, ANDA applicants submit 
approximately 6,054 annual reports, and BLA applicants submit 
approximately 16 annual reports each year that are subject to the 
requirements of the final rule. As explained in section V of the final 
rule, we estimate that the hours per response, i.e., the additional 
time necessary for submission of the content of labeling in electronic 
format for these submissions, will be less than 15 minutes.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                            No. of       No. of Responses  per     Total Annual        Hours per
                   21 CFR Section                        Respondents           Respondent           Responses           Response          Total Hours
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New Applications
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314.50                                                               75                   1.48                111                .25               27.75
314.94                                                              160                   4.79                766                .25              191.50
601.14\2\                                                             6                   3.50                 21                .25                5.25
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Supplements
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314.70                                                              272                   6.76              1,839                .25              459.75
314.97                                                              189                  16.98              3,208                .25              802
601.14\3\                                                            35                   2.34                 82                .25               20.5
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Annual Reports
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314.81                                                              306                   8.55              2,617                .25              654.25
314.98                                                              333                  18.18              6,054                .25            1,513.50
601.14\4\                                                             4                   4                    16                .25                4
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Total                                                                                                                                           3,678.50 
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Applications submitted under Sec.   601.2.
\3\Supplements submitted under Sec.   601.12(f)(1) and (f)(2).
\4\Annual reports submitted under Sec.   601.12(f)(3).


    Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4506 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S