Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 15752-15753 [E6-4506]

Download as PDF 15752 Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 22, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–2997 Filed 3–28–06; 8:45am] BILLING CODE 4184–01–M 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. hsrobinson on PROD1PC68 with NOTICES ACTION: Notice. 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 VerDate Aug<31>2005 15:39 Mar 28, 2006 Jkt 208001 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: https://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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 §§ 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 §§ 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 §§ 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 reestimating 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. E:\FR\FM\29MRN1.SGM 29MRN1 Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices New NDAs (§ 314.50), ANDAs (§ 314.94), and BLAs (§ 601.2): Based on the number of submissions during 2005 under the approved collections of information for §§ 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 (§ 314.70), ANDAs (§ 314.97), and BLAs (§ 601.12(f)(1) and (f)(2)): Based on the number of submissions during 2005 under the approved collections of information for §§ 314.70, 314.97, and § 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 (§ 314.81), ANDAs (§ 314.98), and BLAs (§ 601.12(f)(3)): Based on the number of 15753 submissions during 2005 under the approved collections of information for §§ 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 BURDEN1 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours New Applications 314.50 314.94 601.142 75 160 6 1.48 4.79 3.50 111 766 21 .25 .25 .25 27.75 191.50 5.25 272 189 35 6.76 16.98 2.34 1,839 3,208 82 .25 .25 .25 459.75 802 20.5 306 333 4 8.55 18.18 4 2,617 6,054 16 .25 .25 .25 654.25 1,513.50 4 Supplements 314.70 314.97 601.143 Annual Reports 314.81 314.98 601.144 Total 3,678.50 1There are no capital costs or operating and maintenance costs associated with this collection of information. 2Applications submitted under § 601.2. 3Supplements submitted under § 601.12(f)(1) and (f)(2). 4Annual reports submitted under § 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] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S [Docket No. 2006N–0105] Food and Drug Administration hsrobinson on PROD1PC68 with NOTICES Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the VerDate Aug<31>2005 15:39 Mar 28, 2006 Jkt 208001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 information collection contained in FDA regulations entitled ‘‘Environmental Impact Considerations.’’ E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15752-15753]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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: https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses per Total Annual Hours per
21 CFR Section Respondents Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 3,678.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

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