Statement of Organization, Functions, and Delegations of Authority, 58317-58318 [07-5060]
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58317
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
burden of the collection on respondents,
including through the use of automated
collection techniques, when
appropriate, and other forms of
information technology.
Title: Postmarketing Adverse Event
Reporting and Recordkeeping for
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (pursuant
to section 502(b)(1) of the act) appears
on the label of a nonprescription drug
marketed in the United States.
Burden Estimate: FDA is requesting
public comment on estimates of annual
submissions from these respondents,
expected in 2008, as required by Public
Law 109–462 and described in this
guidance. This guidance document
discusses what should be included in a
serious adverse drug event report
submitted under section 760(b)(1) of the
act, including follow-up reports under
760(c)(2) of the act, and how to submit
these reports. The estimates for annual
reporting burden and recordkeeping are
based on FDA’s knowledge of adverse
drug experience reports historically
submitted per year for prescription drug
products and for nonprescription drug
products marketed under an approved
application, including knowledge about
the time needed to prepare the reports
and to maintain records.
FDA receives approximately 2,500
serious adverse event reports for
nonprescription drug products marketed
under approved applications, which
comprise approximately 20 percent of
the overall nonprescription drug market.
Based on this experience, we estimate
between 10,000 and 15,000 (i.e., 12,500)
total annual responses for
nonprescription drugs marketed without
an approved application. FDA estimates
the burden of this collection of
information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Reports of serious adverse drug
events (21 U.S.C. 379aa((b)
and (c))
Annual frequency
per response
50
Total annual
responses
250
Hours per
response
12,500
Total hours
2
25,000
Total
1There
25,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the act also requires
that responsible persons maintain
records of nonprescription adverse
event reports, whether or not the event
is serious, for a period of 6 years. The
draft guidance recommends that
responsible persons maintain records of
efforts to obtain the minimum data
elements for a report of a serious
adverse drug event and any followup
reports. Although the guidance does not
provide recommendations on
recordkeeping activities generally under
section 760(e) of the act, FDA is
providing an estimate for the burden of
this collection. Historically, serious
adverse event reports comprise
approximately two-thirds, and
nonserious adverse event reports
comprise approximately one-third, of
the total number of postmarketing
adverse event reports associated with
drugs and biologic therapeutics (except
vaccines) received by FDA. Based on
this generalization, FDA estimates the
total annual records to be approximately
20,000 records per year. FDA estimates
that it takes 5 hours to maintain each
record and the recordkeeping burden as
follows:
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of
recordkeepers
Recordkeeping (21 U.S.C.
379aa(e)(1))
Annual frequency
per recordkeeping
200
Total annual
records
100
Hours per
record
20,000
5
Total
1There
100,000
100,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Therefore, the estimated annual
reporting burden for this information is
25,000 hours, and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: October 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–5073 Filed 10–11–07; 11:34 am]
IV. Electronic Access
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Total hours
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Substance Abuse and Mental Health
Services Administration
Statement of Organization, Functions,
and Delegations of Authority
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
VerDate Aug<31>2005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Part M of the Substance Abuse and
Mental Health Services Administration
(SAMHSA) Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services at 72, Number 188,
page 55232, September 28, 2007, is
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58318
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
amended to reflect changes to the
structure and functional statements for
the Office of Program Services (OPS),
Division of Management Systems
(DMS). This amendment reflects the
deletion of references to the information
technology (IT) functions within the
functional statement of DMS. In
addition, it reflects the establishment of
a new Division of Technology
Management (DTM), within OPS. These
changes will strengthen the
management of this key function (IT)
and provide better customer service and
program coordination. The changes are
as follows:
Section M.20, Functions is amended
as follows:
The functional statements for the
Office of Program Services (OPS),
Division of Management Systems (DMS)
is replaced, and a new functional
statement within OPS is established for
the new Division of Technology
Management (DTM).
sroberts on PROD1PC70 with NOTICES
Division of Management Systems (MBC)
(1) Provides leadership in the
development of policies for and the
analysis, performance measurement,
and improvement of SAMHSA
administrative and management
systems; (2) coordinates with other
service providers the provision of
human resource management services,
equal employment opportunity services,
and personnel security services,
working with HHS service components
and outside organizations as necessary
and monitoring their performance; (3)
manages the SAMBHSA ethics program;
(4) coordinates and serves as a focal
point for SAMHSA intern and summer
employment programs; (5) provides
advisory services to managers and
supervisors in such matters as
organizational development, analysis,
performance, and performance
measurement; (6) coordinates General
Accounting Office and Office of the
Inspector General reviews and
information requests, internal control
reviews, and Federal Managers
Financial Integrity Act responses; (7)
plans and coordinates various
management activities such as records
management, forms management,
Privacy Act, and OPS Freedom of
Information Act requests; (8)
coordinates the Competitive Sourcing
program for the agency, including the
annual Federal Activities Inventory
Reform Act (FAIR Act) Inventory, and
activities and studies conducted in
accordance in OMB Circular A–76,
regarding competition of commercial
activities; (9) develops, maintains, and
manages administrative management
VerDate Aug<31>2005
21:55 Oct 12, 2007
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systems regarding policies and
procedures.
DEPARTMENT OF HOMELAND
SECURITY
Division of Technology Management
(MBJ)
U.S. Citizenship and Immigration
Services
(1) Provides leadership in the
development of policies for and the
analysis, performance measurement,
and improvement of SAMHSA
information systems; (2) Manages,
operates, and enhances SAMHSA-wide
administrative applications software
systems; (3) coordinates with other
service providers the provision of IT
services, including operation of the
local and wide area networks, personal
computers, network servers, electronic
mail and faxes, and general computer
repairs, working with HHS service
components and outside organizations
as necessary and monitoring their
performance; (4) serves as the Agency
focal point for IT policy, strategic
planning, budget preparation,
coordination with the Department
regarding these issues, and the
submission of required reports to the
Department on a timely basis; (5) makes
certain that the appropriate level of IT
security is in place so that the safety of
Agency data can be assured; (6) oversees
Agency-wide database administration
and systems configuration management,
providing advice, assistance, and
training to Agency staff to obtain
maximum utilization of and services
from its information/application
systems and databases; (7) exercises
clearance authority for Agency IT
management projects; and (8) reviews
and analyzes new IT management
developments and ensures necessary
support services are provided.
Agency Information Collection
Activities: Form I–566, Extension of an
Existing Information Collection;
Comment Request
Delegation of Authority
All delegations and redelegations of
authority to officers and employees of
SAMHSA which were in effect
immediately prior to the effective date
of this reorganization shall continue to
be in effect pending further
redelegations, providing they are
consistent with the reorganization.
These organizational changes are effective:
October 9, 2007.
Terry L. Cline,
Administrator.
[FR Doc. 07–5060 Filed 10–12–07; 8:45 am]
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30-Day Notice of Information
Collection Under Review: Form I–566,
Interagency Record of Individual
Requesting Change/Adjustment to or
From A or G Status or Requesting A, G,
or NATO Dependent Employment
Authorization; OMB Control No. 1615–
0027.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on July 30, 2007, at 72 FR
41515. The notice allowed for a 60-day
public comment period. No comments
were received on this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until November 14,
2007. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Management Division, Clearance Office,
111 Massachusetts Avenue, 3rd floor,
Washington, DC 20529. Comments may
also be submitted to DHS via facsimile
to 202–272–8352 or via e-mail at
rfs.regs@dhs.gov, and to the OMB USCIS
Desk Officer via facsimile at 202–395–
6974 or via e-mail at
kastrich@omb.eop.gov.
When submitting comments by e-mail
please make sure to add OMB Control
Number 1615–0027 in the subject box.
Written comments and suggestions from
the public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
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]]>Agencies
[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58317-58318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5060]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Statement of Organization, Functions, and Delegations of
Authority
Part M of the Substance Abuse and Mental Health Services
Administration (SAMHSA) Statement of Organization, Functions, and
Delegations of Authority for the Department of Health and Human
Services at 72, Number 188, page 55232, September 28, 2007, is
[[Page 58318]]
amended to reflect changes to the structure and functional statements
for the Office of Program Services (OPS), Division of Management
Systems (DMS). This amendment reflects the deletion of references to
the information technology (IT) functions within the functional
statement of DMS. In addition, it reflects the establishment of a new
Division of Technology Management (DTM), within OPS. These changes will
strengthen the management of this key function (IT) and provide better
customer service and program coordination. The changes are as follows:
Section M.20, Functions is amended as follows:
The functional statements for the Office of Program Services (OPS),
Division of Management Systems (DMS) is replaced, and a new functional
statement within OPS is established for the new Division of Technology
Management (DTM).
Division of Management Systems (MBC)
(1) Provides leadership in the development of policies for and the
analysis, performance measurement, and improvement of SAMHSA
administrative and management systems; (2) coordinates with other
service providers the provision of human resource management services,
equal employment opportunity services, and personnel security services,
working with HHS service components and outside organizations as
necessary and monitoring their performance; (3) manages the SAMBHSA
ethics program; (4) coordinates and serves as a focal point for SAMHSA
intern and summer employment programs; (5) provides advisory services
to managers and supervisors in such matters as organizational
development, analysis, performance, and performance measurement; (6)
coordinates General Accounting Office and Office of the Inspector
General reviews and information requests, internal control reviews, and
Federal Managers Financial Integrity Act responses; (7) plans and
coordinates various management activities such as records management,
forms management, Privacy Act, and OPS Freedom of Information Act
requests; (8) coordinates the Competitive Sourcing program for the
agency, including the annual Federal Activities Inventory Reform Act
(FAIR Act) Inventory, and activities and studies conducted in
accordance in OMB Circular A-76, regarding competition of commercial
activities; (9) develops, maintains, and manages administrative
management systems regarding policies and procedures.
Division of Technology Management (MBJ)
(1) Provides leadership in the development of policies for and the
analysis, performance measurement, and improvement of SAMHSA
information systems; (2) Manages, operates, and enhances SAMHSA-wide
administrative applications software systems; (3) coordinates with
other service providers the provision of IT services, including
operation of the local and wide area networks, personal computers,
network servers, electronic mail and faxes, and general computer
repairs, working with HHS service components and outside organizations
as necessary and monitoring their performance; (4) serves as the Agency
focal point for IT policy, strategic planning, budget preparation,
coordination with the Department regarding these issues, and the
submission of required reports to the Department on a timely basis; (5)
makes certain that the appropriate level of IT security is in place so
that the safety of Agency data can be assured; (6) oversees Agency-wide
database administration and systems configuration management, providing
advice, assistance, and training to Agency staff to obtain maximum
utilization of and services from its information/application systems
and databases; (7) exercises clearance authority for Agency IT
management projects; and (8) reviews and analyzes new IT management
developments and ensures necessary support services are provided.
Delegation of Authority
All delegations and redelegations of authority to officers and
employees of SAMHSA which were in effect immediately prior to the
effective date of this reorganization shall continue to be in effect
pending further redelegations, providing they are consistent with the
reorganization.
These organizational changes are effective: October 9, 2007.
Terry L. Cline,
Administrator.
[FR Doc. 07-5060 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-M
