[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]
[Page 74924-74926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-55]
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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
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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