Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance, Emergency Use Authorization of Medical Products, 51285-51287 [E9-24048]
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51285
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
demographic questions will be
included. The form will ask participants
to report demographic information,
education, profession, field of study,
status of certification or licensure,
workplace role, and employment
setting.
Follow-up Form for Training: The
Follow-up Information Form for
Training asks about 25 questions of
about 25% of consenting participants.
The approved form asks the participants
to report satisfaction with, usefulness of,
and quality of the training and training
materials as well as to assess their level
of skills in the topic area. The form also
asks participants to report whether or
not they have shared information from
the event at their place of work and
which, if any, barriers they have
encountered to applying the information
gained from the training. This form is
already approved by OMB and will not
be revised (OMB #0930–0216).
The information collected on the
ATTC forms will assist CSAT in
documenting the numbers and types of
participants in ATTC events, describing
Number of
respondents
Type of respondent
Faculty/staff Event Description Form ...............................................................
Meeting and Technical Assistance Participants:
Post-Event Form .......................................................................................
Follow-up Form .........................................................................................
Responses
per
respondent
250
Hours per
response
1
30,000
7,500
Total ...................................................................................................
42,750
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Dated: September 28, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–24017 Filed 10–5–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2009–N–0163]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance,
Emergency Use Authorization of
Medical Products
AGENCY:
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:
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.
VerDate Nov<24>2008
16:15 Oct 05, 2009
Jkt 220001
DATES: Fax written comments on the
collection of information by November
5, 2009.
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB Control Number 0910–0595. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
Food and Drug Administration
Draft Guidance, Emergency Use
Authorization of Medical Products—
(OMB Control Number 0910–0595)—
Extension
The draft guidance describes the
agency’s general recommendations and
procedures for issuance of emergency
use authorizations (EUA) under section
564 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
PO 00000
Frm 00033
Fmt 4703
.25
Total annual
burden hours
62.50
5,000
1
.12
600
Covered under CSAT Government Performance and Results Act
(GPRA) Customer Satisfaction form (OMB #0930–0197)
Training Participants:
Post-Event Form .......................................................................................
Follow-up Form .........................................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
the extent to which participants report
improvement in their clinical
competency, and which method is most
effective in disseminating knowledge to
various audiences. This type of
information is crucial to support CSAT
in complying with GPRA reporting
requirements and will inform future
development of knowledge
dissemination activities.
The chart below summarizes the
annualized burden for this project.
Sfmt 4703
1
1
.16
.16
4,800
1,200
6,662.50
360bbb–3), which was amended by the
Project BioShield Act of 2004 (Pub. L.
108–276). The act permits the FDA
Commissioner (the Commissioner) to
authorize the use of unapproved
medical products or unapproved uses of
approved medical products during an
emergency declared under section 564
of the act. The data to support issuance
of an EUA must demonstrate that, based
on the totality of the scientific evidence
available to the Commissioner,
including data from adequate and wellcontrolled clinical trials (if available), it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing a serious or lifethreatening disease or condition (21
U.S.C. 360bbb–3(c)). Although the exact
type and amount of data needed to
support an EUA may vary depending on
the nature of the declared emergency
and the nature of the candidate product,
FDA recommends that a request for
consideration for an EUA include
scientific evidence evaluating the
product’s safety and effectiveness,
including the adverse event profile for
diagnosis, treatment, or prevention of
the serious or life-threatening disease or
condition, as well as data and other
information on safety, effectiveness,
risks and benefits, and (to the extent
available) alternatives.
Under section 564 of the act, the FDA
Commissioner may establish conditions
on the approval of an EUA. Section
564(e) requires the FDA Commissioner
(to the extent practicable given the
E:\FR\FM\06OCN1.SGM
06OCN1
51286
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
circumstances of the emergency) to
establish certain conditions on an
authorization that the Commissioner
finds necessary or appropriate to protect
the public health and permits the FDA
Commissioner to establish other
conditions that he finds necessary or
appropriate to protect the public health.
Conditions authorized by section 564(e)
of the act include, for example:
Requirements for information
dissemination to health care providers
or authorized dispensers and product
recipients; adverse event monitoring
and reporting; data collection and
analysis; recordkeeping and records
access; restrictions on product
advertising, distribution, and
administration; and limitations on good
manufacturing practices requirements.
Some conditions, the statute specifies,
are mandatory to the extent practicable
for authorizations of unapproved
products and discretionary for
authorizations of unapproved uses of
approved products. Moreover, some
conditions may apply to manufacturers
of an EUA product, while other
conditions may apply to any person
who carries out any activity for which
the authorization is issued. Section 564
of the act also gives the FDA
Commissioner authority to establish
other conditions on an authorization
that he finds to be necessary or
appropriate to protect the public health.
For purposes of estimating the burden
of reporting, FDA has established six
categories of respondents: (1) Those
who file a Request for Consideration for
an EUA and, in lieu of submitting the
data, provide reference to a pending or
approved application; (2) those who file
a Request for Consideration for an EUA,
without reference to a pending or
approved application; (3) those who
submit pre-EUA submissions to FDA on
a candidate EUA product, which
references a pending or approved
application; (4) those who submit preEUA submissions to FDA on a candidate
EUA product, for which there is no
reference to a pending or approved
application; (5) manufacturers of an
unapproved EUA product who must
report to FDA regarding such activity;
and (6) state and local public health
officials who carry out an activity
related to an unapproved EUA product
(e.g., administering the product to
recipients) and who must report to FDA
regarding such activity.
For purposes of estimating the burden
of recordkeeping, FDA has calculated
the anticipated burden on
manufacturers of unapproved products
authorized for emergency use. FDA also
anticipates that some state and local
public health officials may be required
to perform additional recordkeeping
(e.g., related to the administration of
unapproved EUA products to civilians)
and calculated a recordkeeping burden
for those activities.
No burden was attributed to reporting
or recordkeeping for unapproved uses of
approved products, since those products
already are subject to approved
collections of information (adverse
experience reporting for biological
products is approved under OMB
Control No. 0910–0308 through
September 30, 2011; adverse drug
experience reporting is approved under
OMB Control No. 0910–0230 through
July 31, 2012; investigational new drug
application regulations are approved
under OMB Control No. 0910–0014
through August 31, 2011; and
investigational device exemption
reporting is approved under OMB
Control Number 0910–0078 through
January 31, 2010). Thus, FDA estimates
the burden of this collection of
information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Requests for Consideration;
Pending Application on File
5
2
10
15
150
Requests for Consideration; No
Application Pending
4
2
8
50
400
Pre-EUA Submissions; Pending
Application on File
2
2
4
20
80
Pre-EUA Submissions; No Application Pending
11
2
22
75
1,650
Manufacturers of an Unapproved
EUA Product
3
4
12
2
24
State and Local Public Health Officials; Unapproved EUA Product
30
4
360
2
240
Total
1 There
2,544
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
Manufacturers of an Unapproved
EUA Product
3
4
12
25
300
State and Local Public Health Officials; Unapproved EUA Product
30
4
120
3
360
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16:15 Oct 05, 2009
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
51287
TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1—Continued
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total
660
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden estimate for this
information collection is 3,204 hours.
The estimated reporting burden for this
collection is 2,544 hours, and the
estimated recordkeeping burden is 660
hours.
In the Federal Register of April 20,
2009 (74 FR 17962), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. However, in the period of time
since the 60-day notice was drafted,
there was a determination of public
health emergency involving the 2009
H1N1 virus and multiple declarations
supporting the issuance of EUAs. As a
result of this increased activity and the
likelihood of a continued increase in the
number of EUA and pre-EUA
submissions, on its own initiative, FDA
is providing estimates based on the
number of reports that the agency
received in the past year.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24048 Filed 10–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0465]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Additive
Petitions
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Total Hours
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
VerDate Nov<24>2008
16:15 Oct 05, 2009
Jkt 220001
public comment in response to the
notice. This notice solicits comments on
food additive petitions regarding animal
feed.
DATES: Submit written or electronic
comments on the collection of
information by December 7, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.
regulations.gov. 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:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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.
Food Additive Petitions—21 CFR Part
571 (OMB Control Number 0910–
0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the act specifies the
information that must be submitted by
a petition in order to establish the safety
of a food additive and to secure the
issuance of a regulation permitting its
use.
To implement the provision of section
409 of the act, procedural regulations
have been issued under part 571 (21
CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the law. The
regulations add no substantive
requirements to those indicated in the
law, but seek to explain the
requirements and provide a standard
format for submission of petitions, that
when implemented, will speed up the
time for processing. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in 21 CFR parts 573, 582, and
584. The labeling regulations are
considered by FDA to be crossreferenced to § 571.1, which is the
subject of this same OMB clearance for
food additive petitions.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Pages 51285-51287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24048]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0163]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance,
Emergency Use Authorization of Medical Products
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
November 5, 2009.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB Control Number 0910-0595.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
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.
Draft Guidance, Emergency Use Authorization of Medical Products--(OMB
Control Number 0910-0595)--Extension
The draft guidance describes the agency's general recommendations
and procedures for issuance of emergency use authorizations (EUA) under
section 564 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360bbb-3), which was amended by the Project BioShield Act of
2004 (Pub. L. 108-276). The act permits the FDA Commissioner (the
Commissioner) to authorize the use of unapproved medical products or
unapproved uses of approved medical products during an emergency
declared under section 564 of the act. The data to support issuance of
an EUA must demonstrate that, based on the totality of the scientific
evidence available to the Commissioner, including data from adequate
and well-controlled clinical trials (if available), it is reasonable to
believe that the product may be effective in diagnosing, treating, or
preventing a serious or life-threatening disease or condition (21
U.S.C. 360bbb-3(c)). Although the exact type and amount of data needed
to support an EUA may vary depending on the nature of the declared
emergency and the nature of the candidate product, FDA recommends that
a request for consideration for an EUA include scientific evidence
evaluating the product's safety and effectiveness, including the
adverse event profile for diagnosis, treatment, or prevention of the
serious or life-threatening disease or condition, as well as data and
other information on safety, effectiveness, risks and benefits, and (to
the extent available) alternatives.
Under section 564 of the act, the FDA Commissioner may establish
conditions on the approval of an EUA. Section 564(e) requires the FDA
Commissioner (to the extent practicable given the
[[Page 51286]]
circumstances of the emergency) to establish certain conditions on an
authorization that the Commissioner finds necessary or appropriate to
protect the public health and permits the FDA Commissioner to establish
other conditions that he finds necessary or appropriate to protect the
public health. Conditions authorized by section 564(e) of the act
include, for example: Requirements for information dissemination to
health care providers or authorized dispensers and product recipients;
adverse event monitoring and reporting; data collection and analysis;
recordkeeping and records access; restrictions on product advertising,
distribution, and administration; and limitations on good manufacturing
practices requirements. Some conditions, the statute specifies, are
mandatory to the extent practicable for authorizations of unapproved
products and discretionary for authorizations of unapproved uses of
approved products. Moreover, some conditions may apply to manufacturers
of an EUA product, while other conditions may apply to any person who
carries out any activity for which the authorization is issued. Section
564 of the act also gives the FDA Commissioner authority to establish
other conditions on an authorization that he finds to be necessary or
appropriate to protect the public health.
For purposes of estimating the burden of reporting, FDA has
established six categories of respondents: (1) Those who file a Request
for Consideration for an EUA and, in lieu of submitting the data,
provide reference to a pending or approved application; (2) those who
file a Request for Consideration for an EUA, without reference to a
pending or approved application; (3) those who submit pre-EUA
submissions to FDA on a candidate EUA product, which references a
pending or approved application; (4) those who submit pre-EUA
submissions to FDA on a candidate EUA product, for which there is no
reference to a pending or approved application; (5) manufacturers of an
unapproved EUA product who must report to FDA regarding such activity;
and (6) state and local public health officials who carry out an
activity related to an unapproved EUA product (e.g., administering the
product to recipients) and who must report to FDA regarding such
activity.
For purposes of estimating the burden of recordkeeping, FDA has
calculated the anticipated burden on manufacturers of unapproved
products authorized for emergency use. FDA also anticipates that some
state and local public health officials may be required to perform
additional recordkeeping (e.g., related to the administration of
unapproved EUA products to civilians) and calculated a recordkeeping
burden for those activities.
No burden was attributed to reporting or recordkeeping for
unapproved uses of approved products, since those products already are
subject to approved collections of information (adverse experience
reporting for biological products is approved under OMB Control No.
0910-0308 through September 30, 2011; adverse drug experience reporting
is approved under OMB Control No. 0910-0230 through July 31, 2012;
investigational new drug application regulations are approved under OMB
Control No. 0910-0014 through August 31, 2011; and investigational
device exemption reporting is approved under OMB Control Number 0910-
0078 through January 31, 2010). Thus, FDA estimates the burden of this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for 5 2 10 15 150
Consideration
; Pending
Application
on File
----------------------------------------------------------------------------------------------------------------
Requests for 4 2 8 50 400
Consideration
; No
Application
Pending
----------------------------------------------------------------------------------------------------------------
Pre-EUA 2 2 4 20 80
Submissions;
Pending
Application
on File
----------------------------------------------------------------------------------------------------------------
Pre-EUA 11 2 22 75 1,650
Submissions;
No
Application
Pending
----------------------------------------------------------------------------------------------------------------
Manufacturers 3 4 12 2 24
of an
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
State and 30 4 360 2 240
Local Public
Health
Officials;
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
Total 2,544
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Recordkeeping Annual Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
Manufacturers 3 4 12 25 300
of an
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
State and 30 4 120 3 360
Local Public
Health
Officials;
Unapproved
EUA Product
----------------------------------------------------------------------------------------------------------------
[[Page 51287]]
Total 660
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual burden estimate for this information collection is 3,204
hours. The estimated reporting burden for this collection is 2,544
hours, and the estimated recordkeeping burden is 660 hours.
In the Federal Register of April 20, 2009 (74 FR 17962), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, in the
period of time since the 60-day notice was drafted, there was a
determination of public health emergency involving the 2009 H1N1 virus
and multiple declarations supporting the issuance of EUAs. As a result
of this increased activity and the likelihood of a continued increase
in the number of EUA and pre-EUA submissions, on its own initiative,
FDA is providing estimates based on the number of reports that the
agency received in the past year.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24048 Filed 10-5-09; 8:45 am]
BILLING CODE 4160-01-S
