FDAAA emergency notice pub 12-12-07 72 FR 70599

Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
Parkway, Cincinnati, Ohio 45226,
telephone 513/533–8320.
Reference:
NIOSH [2006]. Approaches to safe
nanotechnology: an information
exchange with NIOSH. Cincinnati, OH:
Department of Health and Human
Services, Centers for Disease Control
and Prevention, National Institute for
Occupational Safety and Health, July
2006. Web address for this document:
http://www.cdc.gov/niosh/topics/
nanotech/safenano/.
Dated: December 5, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–24047 Filed 12–11–07; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0472]

Agency Emergency Processing Under
the Office of Management and Budget
Review; Certification to Accompany
Drug, Biological Product, and Device
Applications or Submissions
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information concerns the certification to
accompany human drug, biological
product, and device applications or
submissions.

Fax written comments on the
collection of information by December
17, 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, or e-mailed to
[email protected]. All comments
should be identified with the OMB
control number 0910–NEW and title,
‘‘Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.

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DATES:

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FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. 301–827–
4659.
FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13). The
emergency processing was requested in
order to comply with the provisions of
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85),
which require this certification to be
submitted to FDA beginning no later
than December 26, 2007. This
information will be needed immediately
to implement these provisions of
FDAAA, and it is essential to the
agency’s mission of protecting and
promoting the public health. Since the
statutory deadline for collecting the
information is December 26, 2007, the
lack of a form would result in confusion
for the sponsors/applicants as the
information necessary for FDA to carry
out its future statutory responsibilities
would not be obvious without the form.
While some sponsors/applicants may
submit information, it most likely
would neither be complete nor provided
in a systematic fashion so that it can be
more easily retrieved.
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.

SUPPLEMENTARY INFORMATION:

Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
282(j)(5)(B)), will be submitted in the
form of a certification with applications
and submissions currently submitted to
FDA under part 312 (21 CFR part 312)
and 21 CFR part 314 (human drugs)

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70599

approved under OMB control numbers
0910–0014 (expires May 31, 2009) and
0910–0001 (expires May 31, 2008),
respectively, part 312 and 21 CFR part
601 (biological products) approved
under OMB control numbers 0910–0014
and 0910–0338 (expires June 30, 2010)
and 21 CFR parts 807 and 814 (devices)
approved under OMB control numbers
0910–0120 (expires August 31, 2010)
and 0910–0231 (expires November 30,
2010), respectively.
Title VIII of FDAAA amended the
PHS Act by adding section 402(j) (42
U.S.C. 282(j)). The new provisions
require additional information to be
submitted to the clinical trials data bank
(ClinicalTrials.gov) previously
established by the National Institutes of
Health/National Library of Medicine,
including expanded information on
clinical trials and information on the
results of clinical trials. The provisions
include new responsibilities for FDA as
well as several amendments to the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
One new provision, section
402(j)(5)(B) of the PHS Act, requires that
a certification accompany human drug,
biological, and device product
submissions made to FDA. Specifically,
at the time of submission of an
application under sections 505, 515, or
520(m) of the FD&C Act (21 U.S.C. 354,
360e, or 360j(m)), or under section 351
of the PHS Act (21 U.S.C. 262), or
submission of a report under section
510(k) of the FD&C Act (21 U.S.C.
360(k)), such application or submission
must be accompanied by a certification
that all applicable requirements of
section 402(j) of the PHS Act have been
met. Where available, such certification
must include the appropriate National
Clinical Trial (NCT) numbers.
The proposed collection of
information is necessary to satisfy the
above statutory requirement.
The importance of obtaining these
data relates to adherence to the legal
requirements for submissions to the
clinical trials registry and results data
bank and ensuring that individuals and
organizations submitting applications or
reports to FDA under the listed
provisions of the FD&C Act or the PHS
Act adhere to the appropriate legal and
regulatory requirements for certifying to
having complied with those
requirements. The failure to submit the
certification required by section
402(j)(5)(B) of the PHS Act, and the
knowing submission of a false
certification are both prohibited acts
under section 301 of the FD&C Act (21
U.S.C. 331). Violations are subject to
civil money penalties.

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70600

Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices

Investigational New Drug Applications
FDA’s Center for Drug Evaluation and
Research (CDER) received 1,837
investigational new drug applications
(INDs) and 24,581 new IND
amendments in fiscal year (FY) 2004.
CDER anticipates that IND and
amendment submission rates will
remain at or near this level in the near
future.
FDA’s Center for Biologics Evaluation
and Research (CBER) received 227 new
INDs and 6,689 new IND amendments
in FY 2004. CBER anticipates that IND
and amendment submission rates will
remain at or near this level in the near
future.
The estimated total number of
submissions (new INDs and new
submissions) subject to mandatory
certification requirements under section
402(j)(5)(B) of the PHS Act is 26,418 for
CDER plus 6,916 for CBER, or 33,334
submissions per year. The minutes per
response is the estimated number of
minutes that a respondent would spend
preparing the information to be
submitted to FDA under section
402(j)(5)(B) of the PHS Act, including
the time it takes to type the necessary
information.
Based on its experience reviewing
INDs and consideration of the
previously mentioned information, FDA
estimated that approximately 15.0
minutes on average would be needed
per response for certifications which
accompany IND applications and

submissions. It is assumed that most
submissions to investigational
applications will reference only a few
protocols with NCT numbers prior to
FDA submission. It is also assumed that
the sponsor/applicant/submitter has
electronic capabilities allowing them to
retrieve the information necessary to
complete the form in an efficient
manner.
Marketing Applications/Submissions
CDER and CBER received 214 new
drug applications (NDA)/biologics
license applications (BLA)/
resubmissions and 8,535 NDA/BLA
amendments in FY 2004. CDER and
CBER received 259 efficacy
supplements/resubmissions to
previously approved NDAs/BLAs, 2,500
manufacturing submissions, and 1,273
labeling submissions in FY 2004. CDER
and CBER anticipate that new drug/
biologic and efficacy supplement
submission rates will remain at or near
this level in the near future.
FDA’s Center for Devices and
Radiological Health (CDRH) received 51
new premarket approvals (PMA), 3,635
510(k) submissions, and 9 humanitarian
device exemptions (HDE) or 3,695 new
applications in FY 2004. CDRH received
2,267 PMA/510(k)/HDE amendments in
FY 2004. CDRH received 2,705 PMA/
510(k)/HDE supplements in FY 2004.
CDRH anticipates that application,
amendment, and supplement rates will
remain at or near this level in the near
future.

The estimated total number of new
submissions (new marketing
applications, amendments, and
supplements) subject to the mandatory
certification requirements under section
402(j)(5)(B) of the PHS Act is 12,781 for
CDER and CBER plus 8,667 for CDRH or
21,448 new submissions per year.
The total burden estimate includes all
submissions for possible inclusion in
the clinical trials data bank (results).
The minutes per response is the
estimated number of hours that a
respondent would spend preparing the
information to be submitted to FDA
under section 402(j)(5)(B) of the PHS
Act, including the time it takes to type
the necessary information and compile
a list of relevant NCT numbers.
Based on its experience reviewing
NDAs, BLAs, PMAs, HDEs, and 510(k)s,
and consideration of the previously
mentioned information, FDA estimated
that approximately 45.0 minutes on
average would be needed per response
for certifications which accompany
NDA, BLA, PMA, HDE, and 510(k)
applications and submissions. It is
assumed that the sponsor/applicant/
submitter has electronic capabilities
allowing them to retrieve the
information necessary to complete the
form in an efficient manner.
Table 1 of this document provides an
estimate of the annual reporting burden
for the submission of information to
satisfy the requirements of section
402(j)(5)(B) of the PHS Act.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

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Investigational
applications

Marketing
applications

Hours per
response

Total hours

CDER (new application)

1,837

----

.25

459

CBER (new application)

227

----

.25

57

CDER (amendment)

24,581

----

.25

6,145

CBER (amendment)

6,689

----

.25

1,672

CDER/CBER (new application/resubmission)

----

214

.75

161

CDRH (new application)

----

3,695

.75

2,771

CDER/CBER (amendment)

----

8,535

.75

6,401

CDRH (amendment)

----

2,267

.75

1,700

CDER/CBER (efficacy supplement/resubmission)

----

259

.75

194

CDER/CBER (manufacturing supplement)

----

2,500

.75

1,875

CDER/CBER (labeling supplement)

----

1,273

.75

955

CDRH (supplement)

----

2,705

.75

2,029

TOTAL
1 There

24,419
are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
We believe the estimate, 24,419 hours
per year, accurately reflects the burden.
We recognize that individuals or entities
less familiar with FDA forms and the
Clinical Trials Data Bank may require
greater than 15 and 45 minutes
(depending on the type of application/
submission) per response.
Dated: December 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–6023 Filed 12–7–07; 1:06 pm]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.

The following request has been
submitted to OMB for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Ryan White HIV/
AIDS Program Annual Data Report:
Data Report Form: (OMB No. 0915–
0253)—Revision
The Ryan White HIV/AIDS Program
Annual Data Report, formerly called the
CARE Act Data Report (CADR), was first
implemented in 2002 by HRSA’s HIV/
AIDS Bureau. It has undergone revisions
to incorporate the legislative changes
that occurred in 2006. Grantees and
their subcontracted service providers
who are funded under Parts A, B, C, and
D of Title XXVI of the Public Health
Service Act, as amended by the Ryan
White HIV/AIDS Treatment
Modernization Act of 2006, (Ryan White
HIV/AIDS Program), fill out the report.
All Parts of the Ryan White HIV/AIDS
Program specify HRSA’s responsibilities
in the administration of grant funds, the
allocation of funds, the evaluation of
programs for the population served, and
the improvement of the quantity and
quality of care. Accurate records of the
providers receiving Ryan White HIV/
AIDS Program Funding, the services
provided, and the clients served,
continue to be critical to the
implementation of the legislation and
thus are necessary for HRSA to fulfill its
responsibilities. Ryan White HIV/AIDS
Number of
grantees

Program under which grantee is funded
Part
Part
Part
Part

A Only ......................................................................................
B Only ......................................................................................
C Only ......................................................................................
D Only ......................................................................................
Subtotal .....................................................................................

56
59
361
90
566

70601

Program Grantees are required to report
aggregate data to HRSA annually. The
Data Report form is filled out by
grantees and their subcontracted service
providers. The report has seven
different sections containing
demographic information about the
service providers, as well as the clients
served, information about the type of
core and support services provided, as
well as the number of clients served,
information about counseling and
testing services, clinical information
about the clients served, demographic
tables for Parts C and D, and
information about the Health Insurance
Program. The primary purposes of the
Data Report are to: (1) Characterize the
organizations where clients receive
services; (2) provide information on the
number and characteristics of clients
who receive Ryan White HIV/AIDS
Program Services; and (3) enable HAB to
describe the type and amount of
services a client receives. In addition to
meeting the goal of accountability to the
Congress, clients, advocacy groups, and
the general public, information
collected on the Data Report is critical
for HRSA, State, and local grantees, and
individual providers to assess the status
of existing HIV-related service delivery
systems.
The response burden for grantees is
estimated as:

Number of
responses

# of hours per
response

1
1
1
1
............................

40
40
20
20
............................

Number of
responses

# of hours per
response

1
1
1
1
1
............................
............................

26
26
44
42
50
............................
............................

Total hour response burden
2,240
2,360
7,220
1,800
13,620

The response burden for service
providers is estimated as:
Number of
providers

Program under which grantee is funded

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Part A Only ......................................................................................
Part B Only ......................................................................................
Part C Only ......................................................................................
Part D Only ......................................................................................
Funded under more than one program ...........................................
Subtotal .....................................................................................
Total for Both Grantees & Providers .................................

Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to [email protected]
or by fax to 202–395–6974. Please direct

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792
653
108
75
703
2,331
2,897

all correspondence to the ‘‘attention of
the desk officer for HRSA.’’

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20,592
16,978
4,752
3,150
35,150
80,622
94,242

Dated: December 6, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–24022 Filed 12–11–07; 8:45 am]
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Total hour response burden

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