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, 74924-74926 [E6-21132]
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Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
information about youth in the program.
Finally, the study will include an
administrative survey of grantees
participating in the study. The proposed
study will include baseline and followup surveys (to be administered
approximately 12 months apart) of
youth ages 9–16 in the MCP program
and will compare changes in key
behaviors for program youth against
changes in behaviors of similar youth
not enrolled in mentoring programs. By
comparing changes for youth in the
MCP program against changes for youth
not in the program, we will be able to
determine if MCP youths’ behaviors are
closer to the norm for their age group at
follow-up than at program intake. If
MCP youths’ behaviors and outcomes
are shown to improve relative to other
groups, the MCP program has
demonstrated the potential for positive
impacts. The survey also will include
some general informational questions
about youth in the study so that HHS,
policy makers, and practitioners can
have a greater understanding of the life
circumstances of these youth and of
some of the challenges they may face.
The youth surveys will focus on
measuring both attitudinal and
behavioral changes in areas targeted by
the MCP program including attitudes
towards and performance in school;
relationships with parents, peers and
teachers; self-esteem; and engagement in
a variety of risk behaviors, including
alcohol and drug use and physical
violence. They also will include
questions about the living situations of
youth in the study, their relationships
with both incarcerated and nonincarcerated caregivers, and their
relationships with other supportive
adults in their communities.
The administrative survey of grantees
will include questions about the
programmatic structure of each grantee.
It will provide information about
variations in program administration,
mentor activities, and youth served.
Respondents: The proposed study
sample consists of a cohort of 625 youth
ages 9–16 in MCP programs operated at
10 or more different program sites.
Survey data will also be collected from
approximately 72 grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
hsrobinson on PROD1PC76 with NOTICES
Student Baseline Survey .............................................................................
Student follow-up Survey .............................................................................
Grantee Survey ............................................................................................
Estimated Total Annual Burden
Hours: 634.5
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
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
VerDate Aug<31>2005
21:31 Dec 12, 2006
Jkt 211001
Number of
responses per
respondent
Average burden
hours per
response
1
1
1
.5
.5
1
625
500
72
comments and suggestions submitted
within 60 days of this publication.
Dated: November 8, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–9666 Filed 12–12–06; 8:45 am]
BILLING CODE 4184–01–M
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.
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.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Total burden
hours
312.5
250
72
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.
ADDRESSES:
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),
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
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
§§ 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 §§ 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 2003 final rule are estimated in this
action.
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 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 (§ 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 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 (§ 314.81),
ANDAs (§ 314.98), and BLAs
(§ 601.12(f)(3)): Based on the number of
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
74925
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 BURDEN1
No. of
Respondents
hsrobinson on PROD1PC76 with NOTICES
21 CFR Section
New Applications
314.50
314.94
601.142
Supplements
314.70
314.97
601.143
Annual Reports
314.81
314.98
601.144
VerDate Aug<31>2005
21:31 Dec 12, 2006
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
75
160
6
.25
.25
.25
27.75
191.50
5.25
6.76
16.98
2.34
1,839
3,208
82
.25
.25
.25
459.75
802
20.5
306
333
4
PO 00000
111
766
21
272
189
35
Jkt 211001
1.48
4.79
3.50
8.55
18.18
4
2,617
6,054
16
.25
.25
.25
654.25
1,513.50
4
Frm 00030
Fmt 4703
Sfmt 4703
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13DEN1
74926
Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Total Reporting Burden Hours
3,678.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Applications submitted under § 601.2.
3 Supplements submitted under § 601.12(f)(1) and (f)(2).
4 Annual reports submitted under § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarket
Surveillance
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
ACTION:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. 2006N–0382]
AGENCY:
Fax written comments on the
collection of information by January 12,
2007.
DATES:
Notice.
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.
Postmarket Surveillance—21 CFR Part
822 (OMB No. 0910–0449)—Extension
Section 522(a) of the Federal Food,
Drug and Cosmetic Act (the act) (21
U.S.C. 360(l)) authorizes FDA to require
manufacturers to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides specific, clear, and flexible
instructions to manufacturers so they
know what information is required in a
PS plan submission. FDA reviews
submissions in accordance with part
822 (21 CFR part 822) in §§ 822.15 to
822.18 of the regulation, which describe
the grounds for approving or
disapproving a PS plan. If this
information is not collected, FDA would
not be able to ensure that the PS will
result in the collection of useful data
that could reveal unforeseen adverse
events or other information necessary to
protect the public health.
Respondents to this collection of
information are those manufacturers
who require PS of their products.
In the Federal Register of October 2,
2006 (71 FR 57973), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
5
1
5
120
600
822.21
3
1
3
40
120
822.26
1
1
1
8
8
822.27
1
1
1
40
40
822.28
1
1
1
40
40
822.29
1
1
1
120
120
822.30
1
1
1
40
40
822.34
hsrobinson on PROD1PC76 with NOTICES
822.9, 822.10
1
1
1
20
20
822.38
10
2
20
120
2,400
Total
1There
3,338
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
21:31 Dec 12, 2006
Jkt 211001
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74924-74926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21132]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
