Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 68430-68431 [E8-27258]
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Federal Register / Vol. 73, No. 223 / Tuesday, November 18, 2008 / Notices
comments. Any additional comments on
this ICR should be submitted to EPA
and OMB within 30 days of this notice.
EPA has established a public docket
for this ICR under docket ID number
EPA–HQ–OECA–2008–0368, which is
available for public viewing online at
https://www.regulations.gov, in person
viewing at the Enforcement and
Compliance Docket in the EPA Docket
Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA Docket
Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Reading Room is (202) 566–1744, and
the telephone number for the
Enforcement and Compliance Docket is
(202) 566–1927.
Use EPA’s electronic docket and
comment system at https://
www.regulations.gov, to submit or view
public comments, access the index
listing of the contents of the docket, and
to access those documents in the docket
that are available electronically. Once in
the system, select ‘‘docket search,’’ then
key in the docket ID number identified
above. Please note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing at https://www.regulations.gov,
as EPA receives them and without
change, unless the comment contains
copyrighted material, Confidential
Business Information (CBI), or other
information whose public disclosure is
restricted by statute. For further
information about the electronic docket,
go to www.regulations.gov.
Title: NSPS for Calciners and Dryers
in Mineral Industries (Renewal).
ICR Numbers: EPA ICR Number
0746.07, OMB Control Number 2060–
0251.
ICR Status: This ICR is scheduled to
expire on January 31, 2009. Under OMB
regulations, the Agency may continue to
conduct or sponsor the collection of
information while this submission is
pending at OMB. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The OMB control numbers for EPA’s
regulations in title 40 of the CFR, after
appearing in the Federal Register when
approved, are listed in 40 CFR part 9,
and displayed either by publication in
the Federal Register or by other
appropriate means, such as on the
related collection instrument or form, if
applicable. The display of OMB control
numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
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Abstract: The New Source
Performance Standards (NSPS) for
Calciners and Dryers in Mineral
Industries (40 CFR part 60, subpart
UUU) were proposed on April 23, 1986
and promulgated on September 28,
1992.
The affected entities are subject to the
General Provisions of the NSPA at 40
CFR part 60, subpart A and any changes,
or additions to the General Provisions
specified at 40 CFR part 60, subpart
UUU.
These standards apply to new,
modified and reconstructed calciners
and dryers at mineral processing plants
that process or produce any of the
following minerals and their
concentrates or any mixture of which
the majority is any of the following
minerals or a combination of these
minerals: Alumina, ball clay, bentonite,
diatomite, feldspar, fire clay, fuller’s
earth, gypsum, industrial sand, kaolin,
lightweight aggregate, magnesium
compounds, perlite, roofing granules,
talc, titanium dioxide, and vermiculite.
Particulate matter is the pollutant
regulated under this subpart. Feed and
product conveyors are not considered
part of the affected facility. Facilities
subject to NSPS subpart LL, Metallic
Mineral Processing Plants are not
subject to this standard. There are
additional processes and process units
at mineral processing plants listed at
60.730(b) which are not subject to the
provisions of this subpart.
Owners or operators are also required
to maintain records of the occurrence
and duration of any startup, shutdown,
or malfunction in the operation of an
affected facility, or any period during
which the monitoring system is
inoperative. Reports, at a minimum, are
required semiannually. These
notifications, reports, and records are
essential in determining compliance,
and are required, in general, of all
sources subject to NSPS.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 20 hours per
response. Burden means the total time,
effort, or financial resources expended
by persons to generate, maintain, retain,
or disclose or provide information to or
for a Federal agency. This includes the
time needed to review instructions;
develop, acquire, install, and utilize
technology and systems for the purposes
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements which have subsequently
PO 00000
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changed; train personnel to be able to
respond to a collection of information;
search data sources; complete and
review the collection of information;
and transmit or otherwise disclose the
information.
Respondents/Affected Entities:
Calciners and dryers at mineral
processing plants that process or
produce any of the following minerals
and their concentrates or any mixture of
which the majority is any of the
following minerals or a combination of
these minerals: Alumina, ball clay,
bentonite, diatomite, feldspar, fire clay,
fuller’s earth, gypsum, industrial sand,
kaolin, lightweight aggregate,
magnesium compounds, perlite, roofing
granules, talc, titanium dioxide, and
vermiculite.
Estimated Number of Respondents:
167.
Frequency of Response: Initially,
occasionally, and semi-annually.
Estimated Total Annual Hour Burden:
6,955.
Estimated Total Annual Cost:
$674,485, which includes $561,485 in
Labor costs, $4,000 in annualized
capital costs, and $109,000 in
Operations & Maintenance (O&M) costs.
Changes in the Estimates: There is no
change in the total estimated burden
currently identified in the OMB
Inventory of Approved ICR Burdens.
Dated: November 12, 2008.
John Moses,
Acting Director, Collection Strategies
Division.
[FR Doc. E8–27311 Filed 11–17–08; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0397]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
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 December
19, 2008.
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68431
Federal Register / Vol. 73, No. 223 / Tuesday, November 18, 2008 / Notices
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
oiralsubmission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0275. 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.
ADDRESSES:
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:
State Enforcement Notifications—(OMB
Control Number 0910–0275—Extension)
Section 310(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 337(b)) authorizes States to
enforce certain sections of the act in
their own names, but provides that
States must notify FDA before doing so.
Section 100.2(d) (21 CFR 100.2(d)) sets
forth the information that a State must
provide to FDA in a letter of notification
when it intends to take enforcement
action under the act against a particular
food located in the State. The
information required under § 100.2(d)
will enable FDA to identify the food
against which the State intends to take
action and advise the State whether
Federal action has been taken against it.
With certain narrow exceptions, Federal
enforcement action precludes State
action under the act.
In the Federal Register of July 18,
2008 (73 FR 41360), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
100.2(d)
1
1 There
Dated: November 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27258 Filed 11–18–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
dwashington3 on PRODPC61 with NOTICES
[Docket No. FDA–2008–D–0559]
Draft Guidance for Industry on Process
Validation: General Principles and
Practices; Availability
AGENCY:
Total Annual
Responses
1
Hours Per
Response
1
Total Hours
10
10
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
FDA has not received any new
enforcement notifications; therefore, the
agency estimates that one or fewer
notifications will be submitted
annually. Although FDA has not
received any new enforcement
notifications in the last 3 years, it
believes these information collection
provisions should be extended to
provide for the potential future need of
a State government to submit
enforcement notifications informing
FDA when it intends to take
enforcement action under the act against
a particular food located in the State.
Food and Drug Administration,
HHS.
ACTION:
Annual Frequency
per Response
Notice.
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SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Process Validation:
General Principles and Practices.’’ FDA
is revising its guidance for industry
entitled ‘‘Guideline on General
Principles of Process Validation,’’ which
issued in May 1987 (the 1987 guidance).
The revised draft guidance promotes a
‘‘lifecycle’’ approach to process
validation that includes scientifically
sound design practices, robust
qualification, and process verification.
When finalized, this draft guidance will
replace the 1987 guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 20, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448;
or to the Communications Staff (HFV–
12), Center for Veterinary Medicine,
Food and Drug Administration, 7519
PO 00000
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Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Brian Hasselbalch, Center for Drug
Evaluation and Research (HFD–320),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm.
4364, Silver Spring, MD 20993–0002,
301–796–3279;
Grace McNally, Center for Drug
Evaluation and Research (HFD–320),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm.
4374, Silver Spring, MD 20993–0002,
301–301–796–3286;
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–1), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–
1448, 301–827–0373; or
Dennis Bensley, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6956.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 73, Number 223 (Tuesday, November 18, 2008)]
[Notices]
[Pages 68430-68431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27258]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0397]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
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
December 19, 2008.
[[Page 68431]]
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 0910-0275.
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.
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.
State Enforcement Notifications--(OMB Control Number 0910-0275--
Extension)
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections
of the act in their own names, but provides that States must notify FDA
before doing so. Section 100.2(d) (21 CFR 100.2(d)) sets forth the
information that a State must provide to FDA in a letter of
notification when it intends to take enforcement action under the act
against a particular food located in the State. The information
required under Sec. 100.2(d) will enable FDA to identify the food
against which the State intends to take action and advise the State
whether Federal action has been taken against it. With certain narrow
exceptions, Federal enforcement action precludes State action under the
act.
In the Federal Register of July 18, 2008 (73 FR 41360), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours Per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d) 1 1 1 10 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated reporting burden for Sec. 100.2(d) is minimal
because enforcement notifications are seldom used by States. During the
last 3 years, FDA has not received any new enforcement notifications;
therefore, the agency estimates that one or fewer notifications will be
submitted annually. Although FDA has not received any new enforcement
notifications in the last 3 years, it believes these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing FDA when it intends to take enforcement action under the act
against a particular food located in the State.
Dated: November 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27258 Filed 11-18-08; 8:45 am]
BILLING CODE 4160-01-S
