Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 79885-79887 [E8-31058]
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Federal Register / Vol. 73, No. 250 / Tuesday, December 30, 2008 / Notices
at the hearing, we will also publish that
notice.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to the State of Washington
announcing an administrative hearing to
reconsider the disapproval of its SPA
reads as follows:
Ms. Robin Arnold-Williams,
Secretary, Department of Social and
Health Services, P.O. Box 45010,
Olympia, WA 98504–5010.
Dear Ms. Arnold-Williams:
I am responding to your request for
reconsideration of the decision to
disapprove the Washington Medicaid
State plan amendment (SPA) 08–002,
which was submitted on January 7,
2008, and disapproved on September
26, 2008. The SPA proposed to add a
methodology to the State plan that
would be used in the event that a
contract with Regional Support Network
to provide mental health services under
a managed care delivery system to the
State of Washington was not continued.
The issues to be considered at the
hearing are:
• Whether the proposed effective date
for the SPA was consistent with the
limitations imposed by applicable
appropriations statutes on the
availability of funding for SPAs, the
requirements of sections 1902(a)(4)(A)
and 1902(a)(30)(A) of the Social
Security Act (the Act) relating to
methods and procedures generally and
for payment rates specifically, and the
implementing regulations at 42 CFR
430.20 and 42 CFR 447.205—which
require advance public notice of
changes in payment rates. The State’s
proposed effective date for the SPA was
earlier than the date of the publication
of the public notice that the State
submitted in support of the SPA.
• Whether Washington provided
adequate documentation to document
the proposed payment rates and
demonstrate that the proposed rates
were consistent with efficiency and
economy as required by section
1902(a)(30)(A) of the Act. Specifically,
the State proposed the use of actuarially
developed rates that included a range of
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22:55 Dec 29, 2008
Jkt 217001
rates as opposed to a single dollar
amount. The State indicated that the
single dollar amount was developed
from the above mentioned rate range,
however, they were not able to provide
either the dollar amount or the
documentation regarding the
construction of the single rate.
I am scheduling a hearing on your
request for reconsideration to be held on
February 5, 2009, at the Centers for
Medicare & Medicaid Services Seattle
Regional Office, 2201 Sixth Avenue,
MS/RX–43, Seattle, Washington 98121,
in order to reconsider the decision to
disapprove SPA 08–002. If this date is
not acceptable, we would be glad to set
another date that is mutually agreeable
to the parties. The hearing will be
governed by the procedures prescribed
by Federal regulations at 42 CFR Part
430.
I am designating Mr. Benjamin Cohen
as the presiding officer. If these
arrangements present any problems,
please contact the presiding officer at
(410) 786–3169. In order to facilitate any
communication which may be necessary
between the parties to the hearing,
please notify the presiding officer to
indicate acceptability of the hearing
date that has been scheduled and
provide names of the individuals who
will represent the State at the hearing.
Sincerely,
Kerry Weems,
Acting Administrator.
Section 1116 of the Social Security
Act (42 U.S.C. section 1316; 42 CFR
section 430.18).
(Catalog of Federal Domestic Assistance
program No. 13.714, Medicaid Assistance
Program.)
Dated: December 22, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–31019 Filed 12–29–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0650]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00097
Fmt 4703
Sfmt 4703
79885
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
existing FDA regulations regarding the
general administrative procedures for a
person to petition the Commissioner of
Food and Drugs (the Commissioner) to
issue, amend, or revoke a rule; to file a
petition for an administrative
reconsideration or an administrative
stay of action; and to request an
advisory opinion from the
Commissioner.
DATES: Submit written or electronic
comments on the collection of
information by March 2, 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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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
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79886
Federal Register / Vol. 73, No. 250 / Tuesday, December 30, 2008 / Notices
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.
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions—(OMB Control
Number 0910–0183)—Extension
The Administrative Procedures Act (5
U.S.C. 553(e)) provides that every
agency shall give an interested person
the right to petition for issuance,
amendment, or repeal of a rule. Section
10.30 (21 CFR 10.30) sets forth the
format and procedures by which an
interested person may submit to FDA, in
accordance with § 10.20 (21 CFR 10.20)
(submission of documents to Division of
Dockets Management), a citizen petition
requesting the the Commissioner to
issue, amend, or revoke a regulation or
order, or to take or refrain from taking
any other form of administrative action.
The Commissioner may grant or deny
such a petition, in whole or in part, and
may grant such other relief or take other
action as the petition warrants.
Respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses or other for-profit
institutions or groups.
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 371(a)), sets forth the format
and procedures by which an interested
person may request reconsideration of
part or all of a decision of the
Commissioner on a petition submitted
under 21 CFR 10.25 (initiation of
administrative proceedings). A petition
for reconsideration must contain a full
statement in a well-organized format of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision involved.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals of
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting from the
Commissioner of FDA a reconsideration
of a matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the act, sets forth
the format and procedures by which an
interested person may request, in
accordance with § 10.20 (submission of
documents to Division of Dockets
Management), the Commissioner to stay
the effective date of any administrative
action.
Such a petition must do the following:
(1) Identify the decision involved; (2)
state the action requested, including the
length of time for which a stay is
requested; and (3) include a statement of
the factual and legal grounds on which
the interested person relies in seeking
the stay. FDA uses the information
provided in the request to determine
whether to grant the petition for stay of
action.
Respondents to this information
collection are interested persons who
choose to file a petition for an
administrative stay of action.
Section 10.85 (21 CFR 10.85), issued
under section 701(a) of the act, sets forth
the format and procedures by which an
interested person may request, in
accordance with § 10.20 (submission of
documents to Division of Dockets
Management), an advisory opinion from
the Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
on a matter of general applicability.
When making a request, the petitioner
must provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner on the
agency’s formal position for matters of
general applicability.
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
10.30
162
3
486
12
5,832
10.33
4
2
8
10
80
10.35
7
2
14
10
140
10.85
2
1
2
16
32
Total
pwalker on PROD1PC71 with NOTICES
1 There
6,084
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
agency records and experience over the
past 3 years. In 2007, FDA received
approximately 162 citizen petitions
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22:55 Dec 29, 2008
Jkt 217001
(§ 10.30), 4 administrative
reconsiderations of action (§ 10.33), 7
administrative stays of action (§ 10.35),
and 2 advisory opinions (§ 10.85).
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Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
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Federal Register / Vol. 73, No. 250 / Tuesday, December 30, 2008 / Notices
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–31058 Filed 12–29–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0451] (formerly
Docket No. 2007N–0321)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Evaluation of the Impact of Distraction
on Consumer Understanding of Risk
and Benefit Information in Direct-toConsumer Prescription Drug
Broadcast Advertisements
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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.
Due to an administrative error, this
document is being republished.
DATES: Fax written comments on the
collection of information by January 29,
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–NEW and
title ‘‘Experimental Evaluation of the
Impact of Distraction on Consumer
Understanding of Risk and Benefit
Information in Direct-to-Consumer
Prescription Drug Broadcast
Advertisements.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
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22:55 Dec 29, 2008
Jkt 217001
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Experimental Evaluation of the Impact
of Distraction on Consumer
Understanding of Risk and Benefit
Information in Direct-to-Consumer
Prescription Drug Broadcast
Advertisements
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and
other FDA regulated products in
carrying out the provisions of the act.
FDA regulations require that
advertisements that make claims about
a prescription drug include a ‘‘fair
balance’’ of information about the
benefits and risks of advertised
products, in terms of both content and
presentation. Ads can present
information in ways that can optimize
or skew the relative balance of risks and
benefits. Both healthcare providers and
consumers have expressed concerns to
FDA about the effectiveness of its
regulation of manufacturers’ Direct-toConsumer (DTC) prescription drug
advertising, especially as it relates to
assuring balanced communication of
risks compared with benefits.
One characteristic of DTC television
broadcast ads is the use of compelling
visuals. Many assert that the visuals
present during the product risk
presentation are virtually always
positive in tone and often depict
product benefits. A consistently raised
question is whether advertising visuals
of benefits interferes with consumers’
understanding and processing of the
risk information in the ad’s audio or
text.
The manner in which required risk
information is presented in DTC ads has
been recently addressed in the Food and
Drug Administration Amendments Act
of 2007 (FDAAA). Section 901(3) of
FDAAA states that the major statement
in DTC broadcast ads ‘‘shall be
presented in a clear, conspicuous and
neutral manner.’’ Further, the Secretary
of Health and Human Services ‘‘shall
establish standards for determining
whether the major statement is
presented in such a manner.’’ FDAAA
does not define how the objective of
‘‘clear, conspicuous, and neutral’’ is to
be achieved.
PO 00000
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79887
The purpose of the proposed study is,
in part, to determine whether the use of
competing, compelling visual
information about potential drug
benefits interferes with viewers’
processing and comprehension of risk
information about drugs in DTC
advertising or with their cognitive
representations of the drugs. Positive
visual images could influence the
processing of risk-related information
and the final representation of the
advertised drug in multiple ways. First,
compelling visuals could simply
distract consumers from carefully
considering and encoding the risk
information. To the extent that
compelling visuals cause them to attend
to or to process risk information less,
participants exposed to risk information
with simultaneous compelling positive
visuals should recall fewer risks (and
perhaps fewer benefits) than do
participants exposed to the risk
information without the positive
visuals. Second, compelling visuals may
affect the way consumers think about
the brand, specifically their attitudes
toward the advertised brand. An
attitude is simply an association
between an object and a degree of
positivity or negativity. Thus, the
impact of varying visual displays during
the presentation of audio risks may be
manifested in varying attitudes toward
the brand. This is important because
brand attitudes may be an important
determinant of future behavior toward
the brand. In contexts where product
information is complex, initial
impressions based on more subtle
processes may have as significant an
impact on behavioral tendencies as
impressions based upon more
‘‘cognitively-effortful’’ factual
information. Because visual cues are
typically easier to process than verbal
information, initial attitudes for this
group are likely to be greatly influenced
by these cues. Under many
circumstances, people rely much less on
facts that they know, such as the
number of risks associated with, for
example, ibuprofen, and much more on
general feelings they have, such as
strong positivity toward a brand, such as
the Advil brand of ibuprofen.
Compelling visuals during the audio
risk presentation of DTC broadcast
advertisements have the potential to
lead a consumer to form a positive
opinion of a drug for no other reason
than that it is presented in the same
context as positive images.
Another purpose of the present study
is to examine the role of textual
elements in the processing of risk
information. Sponsors often place
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]]>Agencies
[Federal Register Volume 73, Number 250 (Tuesday, December 30, 2008)]
[Notices]
[Pages 79885-79887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0650]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions
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 existing FDA regulations regarding the general
administrative procedures for a person to petition the Commissioner of
Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to
file a petition for an administrative reconsideration or an
administrative stay of action; and to request an advisory opinion from
the Commissioner.
DATES: Submit written or electronic comments on the collection of
information by March 2, 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: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
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
[[Page 79886]]
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.
General Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control
Number 0910-0183)--Extension
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that
every agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30)
sets forth the format and procedures by which an interested person may
submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20)
(submission of documents to Division of Dockets Management), a citizen
petition requesting the the Commissioner to issue, amend, or revoke a
regulation or order, or to take or refrain from taking any other form
of administrative action.
The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, not-for-profit institutions and businesses or other
for-profit institutions or groups.
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)),
sets forth the format and procedures by which an interested person may
request reconsideration of part or all of a decision of the
Commissioner on a petition submitted under 21 CFR 10.25 (initiation of
administrative proceedings). A petition for reconsideration must
contain a full statement in a well-organized format of the factual and
legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. The respondent must submit a petition no later
than 30 days after the decision involved. However, the Commissioner
may, for good cause, permit a petition to be filed after 30 days. An
interested person who wishes to rely on information or views not
included in the administrative record shall submit them with a new
petition to modify the decision. FDA uses the information provided in
the request to determine whether to grant the petition for
reconsideration. Respondents to this collection of information are
individuals of households, State or local governments, not-for-profit
institutions, and businesses or other for-profit institutions who are
requesting from the Commissioner of FDA a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
act, sets forth the format and procedures by which an interested person
may request, in accordance with Sec. 10.20 (submission of documents to
Division of Dockets Management), the Commissioner to stay the effective
date of any administrative action.
Such a petition must do the following: (1) Identify the decision
involved; (2) state the action requested, including the length of time
for which a stay is requested; and (3) include a statement of the
factual and legal grounds on which the interested person relies in
seeking the stay. FDA uses the information provided in the request to
determine whether to grant the petition for stay of action.
Respondents to this information collection are interested persons
who choose to file a petition for an administrative stay of action.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
act, sets forth the format and procedures by which an interested person
may request, in accordance with Sec. 10.20 (submission of documents to
Division of Dockets Management), an advisory opinion from the
Commissioner on a matter of general applicability. An advisory opinion
represents the formal position of FDA on a matter of general
applicability. When making a request, the petitioner must provide a
concise statement of the issues and questions on which an opinion is
requested, and a full statement of the facts and legal points relevant
to the request. Respondents to this collection of information are
interested persons seeking an advisory opinion from the Commissioner on
the agency's formal position for matters of general applicability.
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
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
10.30 162 3 486 12 5,832
----------------------------------------------------------------------------------------------------------------
10.33 4 2 8 10 80
----------------------------------------------------------------------------------------------------------------
10.35 7 2 14 10 140
----------------------------------------------------------------------------------------------------------------
10.85 2 1 2 16 32
----------------------------------------------------------------------------------------------------------------
Total 6,084
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates for this collection of information are based
on agency records and experience over the past 3 years. In 2007, FDA
received approximately 162 citizen petitions (Sec. 10.30), 4
administrative reconsiderations of action (Sec. 10.33), 7
administrative stays of action (Sec. 10.35), and 2 advisory opinions
(Sec. 10.85).
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a
[[Page 79887]]
Government-wide, electronic docket management system. Electronic
comments or submissions will be accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31058 Filed 12-29-08; 8:45 am]
BILLING CODE 4160-01-S
