[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74924-74926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0104]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 January 
12, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 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 2003 final rule). The 2003 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),

[[Page 74925]]

abbreviated new drug applications (ANDAs), supplements, and annual 
reports. The 2003 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 2003 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 2003 final rule are estimated in this action.
    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 2003 final rule. As explained in 
section V of the 2003 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.  
314.70, Sec.  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 2003 
final rule. As explained in section V of the 2003 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 2003 
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.
    In the Federal Register of March 29, 2006 (71 FR 15752), FDA 
published a 60-day notice requesting comments on the information 
collection provisions. FDA gave interested parties an opportunity to 
comment on the information collection during the process requesting 
that OMB extend approval of the collection. We received several 
comments. Generally, the comments said that, unlike FDA's 2003 final 
rule, the agency has now identified Extensible Markup Language (XML) as 
the required file format for Structured Product Label documents (SPL). 
The comments said that the March 29, 2006, Federal Register notice does 
not take into account the amount of time required to obtain, install, 
and update the program required to create the electronic files in the 
new format, and that SPL is a relatively new format requiring an 
initial investment in software, training, and process change that 
cannot simply be converted from the Word or PDF version of labeling. 
The comments said that the process for creating the SPL labeling 
includes significant effort in mapping, coding, recreation of the file, 
and quality control.
    We appreciate the comments and believe they raise important issues. 
We will respond to the comments and amend this collection as soon as we 
have gathered sufficient information to address the costs specified in 
the comments. The public will have an opportunity to comment on our 
response at that time.
    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     Total Annual        Hours per
  21 CFR Section      Respondents       per Respondent       Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
New Applications   .................  .................  .................  .................  .................
                                  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
Supplements        .................  .................  .................  .................  .................
 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
Annual Reports     .................  .................  .................  .................  .................
 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

[[Page 74926]]

 
Total Reporting    .................  .................  .................  .................           3,678.50
 Burden Hours
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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: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21132 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S