FR Doc E6-4506

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15752-15753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-105]

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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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