Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order, 15763-15764 [2012-6393]
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15763
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
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 a reconsideration of a
matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the FD&C Act,
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20, 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 FD&C Act
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20, 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.
In accordance with 5 CFR 1320.8(d),
FDA published a 60-day notice for
public comment in the Federal Register
of September 7, 2011 (76 FR 55396), to
which the Agency received one
comment. However, this comment did
not address the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
10.30
10.33
10.35
10.85
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
....................................................................................
....................................................................................
....................................................................................
....................................................................................
207
4
5
4
1
1
1
1
207
4
5
4
24
10
10
16
4,968
40
50
64
Total ..............................................................................
........................
........................
........................
........................
5,122
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 2010, FDA received
approximately 207 petitions (§ 10.30), 4
administrative reconsiderations of
action (§ 10.33), 5 administrative stays
of action (§ 10.35), and 4 advisory
opinions (§ 10.85).
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DATES:
Food and Drug Administration
ADDRESSES:
[Docket No. FDA–2011–N–0625]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
[FR Doc. 2012–6392 Filed 3–15–12; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
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.
17:10 Mar 15, 2012
Jkt 226001
PO 00000
Frm 00047
Fmt 4703
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0184. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Notice.
SUMMARY:
VerDate Mar<15>2010
Fax written comments on the
collection of information by April 16,
2012.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MRN1.SGM
16MRN1
15764
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
collection of information to OMB for
review and clearance.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12 (OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(e)(2)), set forth the
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21 CFR
12.20(d)). Objections and requests must
be submitted within the time specified
in § 12.20(e). Each objection, for which
a hearing has been requested, must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under § 12.24 (21 CFR 12.24)
and do not limit the evidence that may
be presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
In accordance with 5 CFR 1320.8(d),
FDA published a 60-day notice for
public comment in the Federal Register
of September 9, 2011 (76 FR 55922), to
which the Agency received two
comments. However, these comments
did not address the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
12.22 .....................................................................................
1 There
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6393 Filed 3–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0747]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles
mstockstill on DSK4VPTVN1PROD with NOTICES
1
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 16,
2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0575. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
3
Average
burden per
response
Total annual
responses
3
20
Total hours
60
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order
estimate approximately three requests
are received by the Agency annually,
with each requiring approximately 20
hours of preparation time.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
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:
Waiver of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles—21 CFR 514.1(b)(7) and (b)(8)
(OMB Control Number 0910–0575)—
Extension
The Center for Veterinary Medicine
has written this guidance to address a
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
perceived need for Agency guidance in
its work with the animal health
industry. This guidance describes the
procedures that the Agency
recommends for the review of requests
for waiver of in vivo demonstration of
bioequivalence for generic soluble
powder oral dosage form products and
Type A medicated articles.
The Generic Animal Drug and Patent
Term Registration Act of 1988 (Pub. L.
100–670) permitted generic drug
manufacturers to copy those pioneer
drug products that were no longer
subject to patent or other marketing
exclusivity protection. The approval for
marketing these generic products is
based, in part, upon a demonstration of
bioequivalence between the generic
product and pioneer product. This
guidance clarifies circumstances under
which FDA believes the demonstration
of bioequivalence required by the
statute does not need to be established
on the basis of in vivo studies for
soluble powder oral dosage form
products and Type A medicated articles.
The data submitted in support of the
waiver request are necessary to validate
the waiver decision. The requirement to
establish bioequivalence through in vivo
studies (blood level bioequivalence or
clinical endpoint bioequivalence) may
be waived for soluble powder oral
dosage form products or Type A
medicated articles in either of two
alternative ways. A biowaiver may be
granted if it can be shown that the
generic soluble powder oral dosage form
product or Type A medicated article
contains the same active and inactive
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15763-15764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6393]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0625]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Filing Objections and
Requests for a Hearing on a Regulation or Order
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 April
16, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0184.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 15764]]
collection of information to OMB for review and clearance.
Filing Objections and Requests for a Hearing on a Regulation or Order--
21 CFR Part 12 (OMB Control Number 0910-0184)--Extension
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), set
forth the instructions for filing objections and requests for a hearing
on a regulation or order under Sec. 12.20(d) (21 CFR 12.20(d)).
Objections and requests must be submitted within the time specified in
Sec. 12.20(e). Each objection, for which a hearing has been requested,
must be separately numbered and specify the provision of the regulation
or the proposed order. In addition, each objection must include a
detailed description and analysis of the factual information and any
other document, with some exceptions, supporting the objection. Failure
to include this information constitutes a waiver of the right to a
hearing on that objection. FDA uses the description and analysis to
determine whether a hearing request is justified. The description and
analysis may be used only for the purpose of determining whether a
hearing has been justified under Sec. 12.24 (21 CFR 12.24) and do not
limit the evidence that may be presented if a hearing is granted.
Respondents to this information collection are those parties that
may be adversely affected by an order or regulation.
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice
for public comment in the Federal Register of September 9, 2011 (76 FR
55922), to which the Agency received two comments. However, these
comments did not address the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
12.22........................... 3 1 3 20 60
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate for this collection of information is based on
past filings. Agency personnel responsible for processing the filing of
objections and requests for a public hearing on a specific regulation
or order estimate approximately three requests are received by the
Agency annually, with each requiring approximately 20 hours of
preparation time.
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6393 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P
