[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14448-14450]
[FR Doc No: 2021-05367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-N-0314]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Samples and Protocols

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 information collection
requirements relating to the regulations that state that protocols for
samples of biological products must be submitted to the Agency.

DATES: Submit either electronic or written comments on the collection
of information by May 17, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2002-N-0314 for ``Request for Samples and Protocols.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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.

Request for Samples and Protocols

OMB Control Number 0910-0206--Extension

    This information collection supports Agency regulations. Under
section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has
the responsibility to issue regulations that prescribe standards
designed to ensure the safety, purity, and potency of biological
products and to ensure that the biologics licenses for such products
are only issued when a product meets the prescribed standards. Under
Sec.  610.2 (21 CFR 610.2), the Center for Biologics Evaluation and
Research (CBER) or the Center for Drug Evaluation and Research may at
any time require manufacturers of licensed biological products to
submit to FDA samples of any lot, along with the protocols showing the
results of applicable tests, prior to distributing the lot of the
product. In addition to Sec.  610.2, there are other regulations that
require the submission of samples and protocols for specific licensed
biological products: Sec. Sec.  660.6, 660.36, and 660.46 (21 CFR
660.6, 660.36, and 660.46).
    Section 660.6(a) provides requirements for the frequency of
submission of samples from each lot of Antibody to Hepatitis B Surface
Antigen product, and Sec.  660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.6 products subject to official
release by CBER, one sample from each filling of each lot is required
to be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information, including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot.
    Section 660.46(a) contains requirements as to the frequency of
submission of samples from each lot of Hepatitis B Surface Antigen
product, and Sec.  660.46(b) contains the requirements as to the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.46 products subject to official
release by CBER, one sample from each filling of each lot is required
to be submitted along with a protocol consisting of a summary of the
history or manufacture of the product, including all results of each
test for which test results are requested by CBER. After notification
of official release is received, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of the product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
    The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec.  610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec.  660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products, including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 75
manufacturers submitted samples and protocols in fiscal year (FY) 2020
under the regulations cited previously in this document. FDA estimates
that approximately 72 manufacturers submitted protocols under Sec.
610.2, and 3 manufacturers submitted protocols under the regulation
(Sec.  660.6) for the other specific product. FDA received no
submissions under Sec. Sec.  660.36 or 660.46; however, FDA is using
the estimate of one protocol submission under each regulation in the
event that protocols are submitted in the future.
    The estimated total annual responses are based on FDA's final
actions completed in FY 2020 for the various submission requirements of
samples and protocols for the licensed biological products. The average
burden per response is based on information provided by industry. The
burden estimates provided by industry ranged from 1 hour to 5.5 hours.
Under Sec.  610.2, the hours per response are based on the average of
these estimates and rounded to 3 hours. Under the remaining
regulations, the average burden per response is based on the higher end
of the estimate (rounded to 5 or 6 hours) because more information is
generally required to be submitted in the other protocols than under
Sec.  610.2.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     21 CFR Section/activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
610.2, Requests for Samples and               72          82.972           5,974               3          17,922
 Protocols; Official Release....
660.6(b), Protocols.............               3               4              12               5              60
660.36(a)(2) and (b), Samples                  1               1               1               6               6
 and Protocols..................
660.46(b), Protocols............               1               1               1               5               5
                                 -------------------------------------------------------------------------------
    Total.......................              77  ..............           5,988  ..............          17,993
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall decrease of 1,463 hours and a corresponding decrease of 491
responses. We attribute this adjustment to a decrease in the number of
submissions we received over the last few years.

    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05367 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Notices]
[Pages 60870-60871]
[FR Doc No: 2013-24123]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0879; FRL-9400-8]

Exposure Modeling Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: An Exposure Modeling Public Meeting (EMPM) will be held for 1
day on October 8, 2013. This Notice announces the location and time for
the meeting and sets forth the tentative agenda topics.

DATES: The meeting will be held on October 8, 2013, from 9 a.m. to 4
p.m. Requests to participate in the meeting must be received on or
before October 15, 2013.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Office of Pesticide Programs (OPP), One Potomac Yard (North
Building), Fourth Floor Conference Center (N-4830), 2777 S. Crystal
Dr., Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Jim Carleton, Environmental Fate and
Effects Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are required
to conduct testing of chemical substances under the Toxic Substances
Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA),
or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
     Agriculture, Forestry, Fishing and Hunting (NAICS code
11).

     Utilities (NAICS code 22).
     Professional, Scientific and Technical (NAICS code 54).

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0879, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The 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 Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. Background

    On a biannual interval, an Exposure Modeling Public Meeting will be
held for presentation and discussion of current issues related to
modeling pesticide fate, transport, and exposure for risk assessment in
a regulatory context. Meeting dates and abstract requests are announced
through the ``empmlist'' forum on the LYRIS list server at https://lists.epa.gov/read/all_forums.

III. How can I request to participate in this meeting?

    You may submit a request to participate in this meeting to the
person listed under FOR FURTHER INFORMATION CONTACT. Do not submit any
information in your request that is considered Confidential Business
Information. Requests to participate in the meeting, identified by
docket ID number EPA-HQ-OPP-2009-0879, must be received on or before
October 15, 2013.

IV. Tentative Topics for the Meeting

    1. Estimating the magnitude of pesticide effects on avian
reproductive success: Markov Chain nest productivity model (MCnest).
    2. Testing the Surface Water Calculator.
    3. Development of a conceptual model for estimating aquatic
exposure from the use of pesticides on rice using the Pesticide Flooded
Application Model.
    4. Evaluation of North American Free Trade Agreement (NAFTA)
kinetics guidance.
    5. Comparison of multiple spray drift deposition data sets.
    6. Guidance on modeling offsite deposition of pesticides via spray
drift.
    7. Use of the Organization for Economic Co-operation and
Development, European-North American Soil Geographic Information for
Pesticide Studies Tool (OECD-ENASGIPS) in U.S. settings.
    8. A better sorption model for predicting pesticide behavior.
    9. The significance of time-dependent sorption on leaching
potential: A comparison of measured field results and modeled
estimates.
    10. Evaluation of Pesticide Root Zone Model--Ground Water (PRZM-GW)
using long-term ground water monitoring data.
    11. Comparing ground water models--why are there differences?
    12. Modeling pesticide fate and transport through flowing water
bodies for endangered species assessment in the California Central
Valley.
    13. Spatial Aquatic Model (SAM) pilot project update.

List of Subjects

    Environmental protection, Endangered species assessment, Exposure
modeling, Groundwater, Kinetics, Leaching, Pesticide exposure
assessment, Pesticide monitoring, Sorption model, Spray drift, Surface
water calculator.

    Dated: September 17, 2013.
Jim Cowles,
Acting Director, Environmental Fate and Effects Division, Office of
Pesticide Programs.
[FR Doc. 2013-24123 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P


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<META name="generator" content="Food and Drug Administration">
<META name="creation-date" content="24/11/2008 05:00:16 ">
<TITLE>Food and Drug Administration</TITLE>

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 211, 226, 300, 500, 530, 600, 895, and 1271
[Docket No. 2005N-0373]
RIN 0910-AF54
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and
Drugs Intended for Use in Ruminants
AGENCY:  Food and Drug Administration, HHS.
ACTION:  Proposed rule.
SUMMARY:  The Food and Drug Administration (FDA) is proposing to prohibit the use of
certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and
medical devices intended for use in humans and human cells, tissues, and cellular and tissue-
based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for
use in ruminant animals (drugs for ruminants).  FDA is also proposing new recordkeeping
requirements for medical products for humans and drugs for ruminants that are manufactured
from or otherwise contain material from cattle.  FDA is proposing these actions as part of its
continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of,
bovine spongiform encephalopathy (BSE) and related human disease in the United States.
DATES:  Submit written or electronic comments on the proposed rule by [insert date 60 days
after date of publication in the FEDERAL REGISTER]. Submit written comments on the
information collection requirements by [insert date 30 days after date of publication in the
FEDERAL REGISTER]. Requests for an informal hearing on the proposed ban related to

2
medical devices must be submitted by [insert date 30 days after date of publication in the
FEDERAL REGISTER].
ADDRESSES:  You may submit comments, identified by Docket No. 2005N-0373 and RIN
number 0910-AF54, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
•
Federal eRulemaking Portal: http://www.regulations.gov.  Follow the instructions for
submitting comments.
•
Agency Web site: http://www.fda.gov/dockets/ecomments.  Follow the instructions for
submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
•
FAX:<PHONE_NUMBER>.
•
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD  20852.
To ensure more timely processing of comments, FDA is no longer accepting comments
submitted to the agency by e-mail.  FDA encourages you to continue to submit electronic
comments by using the Federal eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name and Docket No(s). and
Regulatory Information Number (RIN) for this rulemaking. All comments received may be
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal

3
information provided. For detailed instructions on submitting comments and additional
information on the rulemaking process, see section VII “Effective Date and Opportunity for
Public Comment” in the SUPPLEMENTARY INFORMATION section of this document.
Docket:  For access to the docket to read background documents or comments received, go to
http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number(s), found in
brackets in the heading of this document, into the "Search" box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.
Information Collection Provisions:  To ensure that comments on the information collection
are received, Office of Management and Budget (OMB) recommends that written comments be
faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202
– 395¹74.
FOR FURTHER INFORMATION CONTACT:
For information concerning products regulated by the Center for Drug Evaluation and
Research:
Vikki Kinsey,
Center for Drug Evaluation and Research (HFD-006),
Food and Drug Administration,
5
515 Security Lane, rm. 5110,
Rockville, MD 20852,
3
01-44
3-55
78
,
e-mail<EMAIL_ADDRESS>For information concerning products regulated by the Center for Biologics Evaluation
and Research:

4
Stephen M. Ripley,
Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration,
1
401 Rockville Pike, rm 594N,
Rockville, MD 20852-1448,
3
01-82
7-62
10
,
e-mail<EMAIL_ADDRESS>For information concerning products regulated by the Center for Devices and
Radiological Health:
Scott G. McNamee,
Center for Devices and Radiological Health,
Food and Drug Administration,
2
094 Gaither Rd., rm. 230,
Rockville, MD 20850,
2
40-27
6-01
05
,
e-
mail<EMAIL_ADDRESS>For information concerning products regulated by the Center for Veterinary Medicine:
Michael J. Popek,
Center for Veterinary Medicine (HFV-144),
Food and Drug Administration,
7
500 Standish Pl.,
Rockville, MD 20855,
3
01-82
7-64
62
,

5
e-
mail<EMAIL_ADDRESS>SUPPLEMENTARY INFORMATION:
Table of Contents
I.  Introduction
II.  Background
A.  Transmissible Spongiform Encephalopathies
B. Bovine Spongiform Encephalopathy
C.  Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
D. BSE Risk Assessments
1.
Harvard-Tuskegee Study
2.
USDA Surveillance Program
3.
BSE Testing for Product Safety Purposes
4.
BSE Infectivity via Medical Products for Humans and Drugs for Ruminants
E.
Cattle Materials
1.
Specified Risk Material
2.
Small Intestine
3.
Mechanically Separated Beef
4.
Nonambulatory Disabled Cattle
5.
Cattle Not Inspected and Passed for Human Consumption
6.
Tallow and Tallow Derivatives
7.
Fetal Calf Serum
8.
Additional Requirements

6
F. Medical Products for Humans and Drugs for Ruminants That May Contain Cattle
Material
1.
Drugs for Humans
2.
Biologics for Humans
3.
HCT/Ps
4.
Medical Devices for Humans
5.
Drugs for Ruminants
III.  USDA/FSIS IFR
IV.  FDA Actions on BSE
A.  Regulations
1.
FDA 1997 Ruminant Feed Rule
2.
FDA/USDA Animal Feed ANPRM and FDA 2005 Animal Feed Proposed
Rule
3.
Foods IFR
4.
Foods Recordkeeping/Access Proposed Rule
B.  FDA Guidance
V.
Description of Proposed Rule
A.  Definitions
B.  Proposed Requirements for Prohibited Cattle Materials and Permission for an
Exception or Alternative to These Requirements
C.  Tallow and Tallow Derivatives
D.  Proposed Requirements Regarding Extralabel Drug Use in Animals
E.
Proposed Recordkeeping Requirements

7
1.
Types of Records
2.
Proposed Periods for Records Retention
3
.
Location of Records
VI.  Legal Authority
VII. Effective Date and Opportunity for Public Comment
VIII.  Analysis of Impacts
A.  Need for the Proposed Rule
B.  Scope of the Proposed Rule
C.  Costs of the Proposed Rule
1.
Potential Market Adjustments
2.
Cost of Requests for Exception or Alternatives to the Limitation on the Use of
Prohibited Cattle Material
3.
Cost of Substitutes
4.
Recordkeeping Requirements of the Proposed Rule
5.
Labeling Costs for Drugs Prohibited from Extralabel Use
6.
Summary of the Cost for the Proposed Rule
D.  Benefits of the Proposed Rule
1.
Reduced Risk of Exposure to BSE Infectivity
2.
Value of the Potential Reduction of Human Illness
E.
Summary of the Potential Costs and Benefits of the Proposed Rule
F.  Regulatory Options Considered
G. Regulatory Flexibility Analysis
IX.  Paperwork Reduction Act Analysis

8
X.
Environmental Impact Analysis
XI.  Federalism
XII.  References
I.  Introduction
On January 26, 2004, the U.S. Department of Health and Human Services announced its
plan to establish new safeguards to strengthen existing firewalls against transmission of BSE in
the United States.  Consumption of products contaminated with the agent that causes BSE has
been linked to the human disease variant Creutzfeldt-Jakob disease (vCJD).  Current protections
against the spread of BSE in the United States include:
•
FDA’s ruminant feed regulation (the 1997 ruminant feed rule) (62 FR 30936,
June 5, 1997) (see section V.A.8 of this document for definition of ruminant),
•
U.S
. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service
(FSIS) interim final rule banning specified risk materials (SRMs) and certain other cattle
material in human food (the USDA/FSIS IFR) (69 FR 1862, January 12, 2004; as amended, 70
FR 53043, September 7, 2005),
•
FDA’s interim final rule banning the use of SRMs and certain other cattle
material in human food, including dietary supplements, and cosmetics (the Foods IFR) (69 FR
422
56, July 14, 2004; as amended, 70 FR 53063, September 7, 2005), and
•
Import controls.
FDA has also proposed requirements for establishment and maintenance of records
concerning use of materials derived from cattle in human food and cosmetics (the Foods
proposed rule) (69 FR 42275, July 14, 2004). In addition, FDA, in conjunction with USDA,
issued an advance notice of proposed rulemaking (ANPRM) to solicit comment on additional
Formatted: Indent: First line: 36 pt
Formatted: Bullets and Numbering
Deleted:

9
measures under consideration, including measures related to animal feeds (the joint ANPRM)
(69 FR 42288, July 14, 2004).  On October 6, 2005 (70 FR 58570), we issued a proposed rule
that would prohibit certain cattle materials from all animal feed (FDA 2005 Animal Feed
proposed rule).
In this medical products proposed rule, FDA is proposing to prohibit use of SRMs and
certain other cattle material in, or in the manufacture (including processing) of, medical products
for humans and drugs for ruminants because of the risk of transmission of BSE.  FDA is also
proposing recordkeeping requirements for medical products for humans and drugs for ruminants
that are manufactured from or otherwise contain material from cattle to ensure compliance with
the prohibitions in this proposed rule.  The proposed requirements are consistent with the
requirements in the USDA/FSIS IFR and the Foods IFR, as well as the proposals in the Foods
Recordkeeping/Access proposed rule.  The proposed requirements in this medical products
proposed rule only apply to medical products for humans and drugs for ruminants.  They do not
apply to any other product regulated by FDA.
II.  Background
A. Transmissible Spongiform Encephalopathies
Transmissible spongiform encephalopathies (TSEs) are fatal neurodegenerative disorders
that have been identified in humans and a number of animal species (e.g., cattle, sheep, goats,
elk, deer, cats, and mink), but primarily in ruminants (i.e., animals that have a stomach with four
compartments, such as cattle and buffalo). A TSE is characterized by a long incubation period,
followed by a shorter course of neurological symptoms, followed by death (Ref. 1).  Postmortem
histopathology of the brain tissue from humans and animals with TSEs is characterized by a

10
sponge-like appearance of the brain and deposits of abnormal forms of certain cell-associated
proteins (normal prion proteins) in the brain.
TSEs in humans include CJD, vCJD, Gerstmann-Sträussler-Scheinker syndrome, kuru,
fatal familial insomnia, and sporadic fatal insomnia (Ref. 8).  Nonhuman TSEs include BSE in
cattle, scrapie in sheep and goats, transmissible mink encephalopathy (TME) in mink, feline
spongiform encephalopathy (FSE) in cats, and chronic wasting disease (CWD) in deer and elk
(Ref. 8).  Scrapie and CWD occur, and TME has occurred, in the United States.  On December
23, 2003, USDA diagnosed BSE in an adult cow in the United States that had been imported
from Canada.  Since then, USDA has confirmed two other cases of BSE in adult cows in the
United States.  One cow, which was diagnosed on June 24, 2005, was born and raised in Texas.
The other cow, which was diagnosed on March 15, 2006, had been on a farm in Alabama for less
than a year. The Texas cow was 12 years old and the Alabama cow was determined to be more
than 10 years old.  Therefore, both cows were born before the 1997 ruminant feed rule was in
place. USDA determined that no part of the animals entered the human food or animal feed
chains.
The pathogenesis of TSEs is poorly understood.  TSE agents resist complete inactivation
by treatments that destroy conventional microorganisms, like bacteria and viruses.  Thus,
conventional microorganisms are not likely causes of TSEs (Ref. 9).  The most widely accepted
explanation for TSEs, the prion theory, suggests that the infectious agents of TSEs are
abnormally folded forms of normal prion proteins (Refs. 10 and 11).  Normal prion protein genes
are found widely in nature.  In mammals, normal prion proteins are primarily expressed in
neurons, but also can be found in other tissues in lower concentrations, depending on the

11
mammalian species (Ref. 12).  It is not well understood how the abnormal folding of prion
proteins occurs or why hosts cannot efficiently dispose of or develop immunity to these proteins.
The current lack of an antemortem diagnostic test for TSEs in either humans or animals
limits surveillance for these diseases, studies of disease pathogenesis, and other research efforts.
Diagnosis is confirmed by special postmortem examination of brain tissue by identification of
abnormal prion proteins in advanced stages of the disease.  At earlier stages of disease
development, abnormal prion proteins are undetectable in brain tissue. Presently, there are no
effective treatments for TSEs, and all TSEs are invariably fatal (Ref. 1).
B.  Bovine Spongiform Encephalopathy
BSE is a TSE of cattle with a long incubation period (up to 8 years or longer), most likely
acquired following consumption of an animal product containing the BSE infectious agent (Refs.
13 and 14).  The British Ministry of Agriculture, Fisheries and Food (now known as the
Department for Environment, Food, and Rural Affairs) first recognized BSE as a distinct disease
in November 1986.  The clinical signs of BSE include behavioral, gait, and postural
abnormalities.  The disease usually presents in cattle as increased apprehension, increased
reaction to sound and touch, and a swaying gait. These signs are accompanied by subtle changes
in the normal behavior of the cow, such as separation from the herd while at pasture,
disorientation, staring, and excessive licking of the nose or flanks.  The disease progresses to
stumbling and falling, and ends with seizures, coma, and death (Ref. 15).
Experiments indicate that the infectious dose for cattle is very low.  One gram of
homogenized brain from affected cattle caused BSE in 7 out of 10 calves fed the brain sample.
Six years after oral consumption of lower doses of brain material, 3 of 15 calves fed 0.1 gram,

12
and 1 of 15 calves fed 0.01 gram, and 1 of 15 calves fed 0.001 gram (1 mg) of brain sample had
developed the disease.  This experiment is ongoing (Ref. 16).
Epidemiological studies have characterized the outbreak of BSE in the United Kingdom
as a prolonged epidemic in which early cases were seen simultaneously at various locations, but
with all occurrences presumably due to a common point source of infection (Ref. 17).
Consistent with this observation, the subsequent spread of BSE was associated with the feeding
of meat-and-bone-meal from rendered BSE-infected cattle to non-infected cattle (Ref. 17).  It
appears likely that the BSE agent was transmitted among cattle at an increasing rate by ruminant-
to-ruminant feeding until the United Kingdom ban on such practices went into effect in 1988
(Ref. 13).  The United Kingdom instituted a ruminant-to-ruminant feed ban to stop the cycle of
infection, restrict the geographic spread of the disease, and eliminate potential sources of new
infections.  Since BSE was first identified in the United Kingdom, approximately 185,000 cattle
have been diagnosed with the disease there (Ref. 18).  The precautionary slaughter of millions of
British cows and increasingly stringent prohibitions on certain animal feeding practices appear to
have slowed, but not eradicated, the BSE epidemic in the United Kingdom. In 1992 (the peak
year of the epidemic), there were over 37,000 cases of BSE in the United Kingdom; in 2005,
there were 225 cases (Ref. 18).
The introduction of BSE into other countries presumably originated from their import of
cattle, or animal feed made with cattle material, from the United Kingdom during the BSE
epidemic (Ref. 13).  In addition to the United Kingdom, BSE has been detected in indigenous
cattle in Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany,
Greece, Israel, Italy, Japan, Liechtenstein, Luxembourg, the Netherlands, Poland, Portugal, the

13
Republic of Ireland, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United States (Ref.
19).
C.
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
Creutzfeldt-Jakob Disease (CJD) is a sporadic disease of humans that exists throughout
the world with an annual incidence of approximately one case per million population (Ref. 10).
The highest death rates in the United States and the United Kingdom occur in individuals
between the ages of 60 and 70 (Ref. 20).  Death generally occurs after less than a year of
progressive neurological deterioration (Ref. 10).  Early symptoms typically include changes in
sleeping and eating patterns, followed by inappropriate behavior and eventual dementia, lack of
coordination, and myoclonic spasms. CJD is always fatal (Ref. 20).  The cause of sporadic CJD
is not fully understood, but genetic susceptibility may play a role (Ref. 10). CJD has been
inadvertently transmitted between humans during medical treatment or diagnostic procedures via
contaminated neurosurgical instruments, transplants of dura mater and corneas, and injection of
pituitary extract (Ref. 10).
In April 1996, British scientists reported a previously undetected new vCJD in young
patients, with symptoms somewhat different from sporadic CJD (Refs. 21 and 22).  All cases of
vCJD had histopathologic evidence of spongiform changes in the brain, but also showed
formation of “florid” plaques (a core of amyloid protein with surrounding halos of vacuoles) not
typically seen in other forms of CJD (Ref. 10).  Clinically, vCJD usually begins with a
psychiatric presentation, such as depression, anxiety, nightmares, or hallucinations.  These
symptoms are followed by memory impairment, then dementia in the late stages.  The clinical
course generally ranges from 9 months to 3 years before death occurs (Ref. 23).  The probable
incubation period for vCJD in humans may range from 5 to more than 20 years (Ref. 39).

14
Scientists have concluded that exposure to the BSE agent is the most plausible
explanation for the occurrence of vCJD (Refs. 24 through 27).  Monkeys (genetically the closest
animal model to humans) inoculated with samples of brain from BSE-infected cattle have been
found to develop a TSE that is histopathologically similar to vCJD (Ref. 28), as have mice
inoculated or fed with BSE-infected tissue (Ref. 29).  Studies have shown that abnormal prion
proteins from vCJD patients are molecularly similar to abnormal prion proteins from BSE-
infected cattle, but different from abnormal prion proteins from patients with CJD (Ref. 23).
Although the exact route of exposure is not known, most scientists believe that vCJD in humans
has been caused by consumption of cattle products contaminated with the agent that causes BSE
(Refs. 20, 30, and 31). There is thought to be a 10- to 10,000-fold increase in the amount of
infectious material needed to cause illness in humans as compared with cattle because of the
species barrier, although the European Commission’s Scientific Steering Committee cautioned
that this range is uncertain and in an unlikely, but worst case scenario, the species barrier may
not exist (Ref. 40).
As of August 2006, 162 probable and confirmed cases of vCJD have been reported in the
United Kingdom (Ref. 32).  In addition, there have been 15 vCJD cases in France, 3 in Ireland, 2
in the United States ,and 1 each in Canada, Italy, the Netherlands, Portugal, Japan, Spain, and
Saudi Arabia (Refs. 33 through 38 and 70).  The two cases in the United States, one of the three
from Ireland, and the single cases from Canada and Japan are likely due to the individual’s
exposure to BSE in the United Kingdom (Refs. 34, 36, and 70).
The infectious dose for humans is not known.  Despite widespread exposure in the United
Kingdom to BSE-contaminated meat products, only a very small percentage of the exposed

15
population has been diagnosed with vCJD to date. This may reflect a partial species barrier to
disease transmission from cattle to humans via the oral route of exposure (Ref. 40).
D.
BSE Risk Assessments
1.
Harvard-Tuskegee Study
In 1998, USDA asked the Harvard Center for Risk Analysis (HCRA) and the Center for
Computational Epidemiology at Tuskegee University to evaluate United States measures to
prevent the spread of BSE to animals and humans if it were to occur in this country.  The
Harvard-Tuskegee risk assessment (the Harvard-Tuskegee study determined that the United
States was highly resistant to any proliferation of BSE or a similar disease (Ref. 41).  The risk
assessment model also demonstrated that certain new control measures could reduce the small
risk even further.
The Harvard-Tuskegee study involved a probabilistic simulation model to determine the
consequences of introducing BSE into the U.S. cattle population. This simulation indicated that,
in a hypothetical situation in which 10 infected cattle were imported into the United States, on
average only 4 new cases of BSE would arise, and the disease would be eliminated in 20 years.
The Harvard-Tuskegee study determined that these new cases of BSE would most likely arise in
the United States from incomplete compliance with the FDA 1997 ruminant feed rule (see
section III.A.1 of this document), and also concluded that an epidemic of BSE in this country
resulting from scrapie, CWD, or another TSE is unlikely.
The Harvard-Tuskegee study estimated the number of cattle infectious doses that might
be available for human exposure, but it did not estimate the likelihood of human disease from
this exposure because the relationship between the two is not known.  According to the study, the
estimated total infectivity available for human exposure from the importation of 10 infected

16
cattle is 39 cattle infectious doses over 20 years.  The Harvard-Tuskegee study determined that
the greatest sources of infectivity to consumers from food are direct consumption of cattle brain
and spinal cord and also meat that contains central nervous system tissue from advanced meat
recovery systems.  The Harvard-Tuskegee study did not address potential human exposure to the


[Federal Register: January 10, 2008 (Volume 73, Number 7)]
[Notices]
[Page 1871]
[DOCID:fr10ja08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket Nos. ER08-25-000, ER08-25-001]

Ocean State Power, Ocean State Power II; Notice of Issuance of
Order

December 27, 2007.
    Ocean State Power and Ocean State Power II (collectively, Ocean
State) filed an application for market-based rate authority, with an
accompanying rate tariff. The proposed market-based rate schedule
provides for the sale of energy, capacity and ancillary services at
market-based rates. Ocean State also requested waivers of various
Commission regulations. In particular, Ocean State requested that the
Commission grant blanket approval under 18 CFR Part 34 of all future
issuances of securities and assumptions of liability by Ocean State.
    On December 18, 2007, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development-West, granted the
requests for blanket approval under Part 34 (Director's Order). The
Director's Order also stated that the Commission would publish a
separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard concerning the blanket approvals of issuances of securities or
assumptions of liability by Ocean State, should file a protest with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2004).
    Notice is hereby given that the deadline for filing protests is
January 18, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Ocean State is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Ocean State, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Ocean State's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-237 Filed 1-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Rules and Regulations]
[Pages 24138-24139]
[FR Doc No: 2012-9708]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs for Use in Animal Feeds; Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Novartis Animal Health US, Inc. The
supplemental NADA provides for approval of a new concentration of a
Type A medicated article.

DATES: This rule is effective April 23, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc. (Novartis),
3200 Northline Ave., Suite 300, Greensboro, NC 27408, filed a
supplement to NADA 139-472 for DENAGARD (tiamulin hydrogen fumarate)
Type A medicated articles for use of a new product formulation in
medicated swine feed. The supplemental NADA is approved as of January
6, 2012, and the regulations in 21 CFR 558.4 and 558.600 are amended to
reflect the approval.
    The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In paragraph (d) of Sec.  558.4, in the ``Category II'' table,
revise the entries for ``Tiamulin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                            Assay limits                          Assay limits
                          Drug                            percent \1\ Type    Type B maximum    percent \1\ Type
                                                                 A                (100x)            B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Tiamulin hydrogen fumarate.............................            90-115            10 g/lb      90-115/70-130

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

0
3. In Sec.  558.600, revise paragraph (a) and the heading of the first
column in the table in paragraph (e)(1) to read as follows:

Sec.  558.600  Tiamulin.

    (a) Specifications. Type A article containing 363.2 grams of
tiamulin hydrogen fumarate per pound.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Tiamulin hydrogen fumarate in
          grams per ton                  * * *               * * *               * * *               * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: April 17, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2012-9708 Filed 4-20-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Notices]
[Pages 12092-12094]
[FR Doc No: 2012-4596]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66442; File No. SR-FINRA-2012-012]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change Relating To
Raising the Limit for Simplified Arbitration

February 22, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
February 9, 2012, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been substantially prepared by
FINRA. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA's Customer and Industry Codes

of Arbitration Procedure to raise the limit for simplified arbitration
from $25,000 to $50,000.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    FINRA is proposing to amend FINRA Rules 12401 (Number of
Arbitrators) and 12800 (Simplified Arbitration) of the Code of
Arbitration Procedure for Customer Disputes (``Customer Code''), and
FINRA Rules 13401 (Number of Arbitrators) and 13800 (Simplified
Arbitration) of the Code of Arbitration Procedure for Industry Disputes
(``Industry Code''), to raise the limit for simplified arbitration from
$25,000 to $50,000.
    Currently, FINRA offers streamlined arbitration procedures for
claimants seeking damages of $25,000 or less. Under the simplified
arbitration rules, one chair-qualified arbitrator decides a claim and
issues an award based on the written submissions of the parties,
unless, in a customer case, the customer requests a hearing, or, in an
industry case, the claimant requests a hearing. FINRA also streamlines
discovery for these cases.
    The $25,000 threshold has been in place since 1998 \3\ and, at that
time, captured 21 percent of all cases filed with the forum. Currently,
the $25,000 threshold captures ten percent of FINRA's caseload.
Statistics for 2011 indicate that raising the threshold to $50,000
would increase the percentage of claims administered under simplified
arbitration to 17 percent of the claims filed with the forum. FINRA
staff believes that raising the threshold for simplified arbitration to
$50,000 would benefit forum users in a number of ways.
---------------------------------------------------------------------------

    \3\ In 1998, FINRA raised the amount in dispute for simplified
arbitration from $10,000 to $25,000. See NASD, Notice to Members 98-
90 (New Arbitrator List Selection Rules And Monetary Thresholds For
Simplified And Single Arbitrator Cases Take Effect).
---------------------------------------------------------------------------

    First, forum fees for simplified arbitration claims would be
reduced. Under FINRA Rules 12800 and 13800, no hearing is held unless
the customer or claimant requests one.\4\ Under the current fee
schedule, FINRA charges $450 per hearing session for claims between
$25,000 and $50,000. Under the proposed rule change, parties who choose
to have their dispute resolved ``on the papers'' (i.e., based on the
pleadings and other materials submitted by the parties) would save the
$450 hearing session fee.\5\ In the event that a case would have
required two hearing sessions (one full day), the fee savings would be
$900.\6\ Further, under Rules 12903 and 13903 (Process Fees Paid by
Members), members are assessed a non-refundable hearing process fee of
$1,000 for claims between $25,000.01 and $50,000 when a hearing date
and location are set. Under the proposal, if the dispute is resolved on
the papers, members would not have to pay this fee.
---------------------------------------------------------------------------

    \4\ Under the simplified procedures for customer cases, only the
customer may request a hearing (regardless of whether the customer
or the firm initiated the arbitration). Under the simplified
procedures in the Industry Code, only the claimant may request a
hearing.
    \5\ Under Rules 12100(n) and 13100(n), a hearing session means
any meeting between the parties and arbitrators of four hours or
less, including a prehearing conference.
    \6\ Since the arbitrator assesses the hearing session fees,
either the claimant or the respondent could realize the savings.
---------------------------------------------------------------------------

    Second, parties would save the time and expense of preparing for,
scheduling, and traveling to the hearing.
    Third, customers who are not able to retain an attorney to handle
their case because of the small amount in dispute, and who are not
comfortable appearing at an evidentiary hearing without representation,
would have the flexibility to choose whether to request a hearing.
    Finally, raising the limit for cases decided on the papers would
reduce the time to process the cases because the arbitrator and parties
would not need to coordinate their calendars to schedule a hearing.
    For the reasons stated above, FINRA is proposing to amend Rules
12401(a) and 13401(a) to provide that if the amount of a claim is
$50,000 or less, exclusive of interest and expenses, the panel would
consist of one arbitrator and the claim would be subject to the
simplified arbitration rules. FINRA would amend Rules 12401(c) and
13401(c) to state that if the amount of a claim is more than $50,000,
but not more than $100,000, exclusive of interest and expenses, the
panel will consist of one arbitrator unless the parties agree in
writing to three arbitrators. The provisions relating to claims of more
than $100,000 would remain the same.
    FINRA is proposing to amend Rules 12800(a) and 13800(a) to provide
that the simplified arbitration rules apply to claims involving $50,000
or less, exclusive of interest and expenses. FINRA would amend Rules
12800(e) and 13800(e) to state that if any pleading increased the
amount in dispute to more than $50,000, FINRA would no longer
administer the claim under the simplified arbitration rules.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\7\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that raising the threshold for
simplified arbitration would, as referenced above, improve efficiency
and reduce fees for claims up to $50,000, enhancing the forum for its
users.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2012-012 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2012-012. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2012-012 and should be
submitted on or before March 20, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-4596 Filed 2-27-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2988-2989]
[FR Doc No: 2013-00644]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14478-000]

 New England Hydropower Company, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On December 28, 2012, the New England Hydropower Company, LLC,
filed an application for a preliminary permit, pursuant to section 4(f)
of the Federal Power Act (FPA), proposing to study the feasibility of
the Eagleville Dam Hydroelectric Project (Eagleville Dam Project or
project) to be located on the Willimantic River, in the towns of
Coventry and Manchester, Tolland County, Connecticut. The sole purpose
of a preliminary permit, if issued, is to grant the permit holder
priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) An
existing 22-foot-high, 520-foot-long earth embankment dam with a 173-
foot-long stone masonry spillway; (2) an existing 77-acre impoundment
with an operating elevation of about 277.0 feet above mean sea level
(msl); (3) an existing 12-foot-long, 16-foot-wide, 10-foot-deep head
box and intake channel; (4) a new 10-foot-high, 16-foot-wide sluice
gate equipped with two existing 10-foot-high, 7-foot-wide trashracks
with 6-inch bar spacing; (5) a new 60-foot-long, 11.25-foot-wide
Archimedes screw generator unit with an installed capacity of 133
kilowatts; (6) a new 10-foot-high, 19-foot-long, 22-foot-wide
powerhouse containing a new gearbox and electrical controls; (7) a new
above ground 215-foot-long, 13.8-kilovolt transmission line connecting
the powerhouse to the Connecticut Light & Power's distribution system;
and (8) appurtenant facilities. The estimated annual generation of the
proposed Eagleville Dam Project would be about 630 megawatt-hours. The
existing Eagleville Dam and appurtenant works, including a former
penstock foundation and intake structures, are owned by the State of
Connecticut and operated by the Connecticut Department of Energy and
Environmental Protection.
    Applicant Contact: Mr. Michael C. Kerr, New England Hydropower
Company, LLC, P.O. Box 5524, Beverly Farms, Massachusetts 01915; phone:
(978) 360-2547.
    FERC Contact: John Ramer; phone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http:[sol][sol]www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at
http:[sol][sol]www.ferc.gov/docs-filing/ecomment.asp. You must include
your name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll

free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and seven copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http:[sol][sol]www.ferc.gov/docs-filing/
elibrary.asp. Enter the docket number (P-14478) in the docket number
field to access the document. For assistance, contact FERC Online
Support.

    Dated: January 9, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-00644 Filed 1-14-13; 8:45 am]
BILLING CODE 6717-01-P


<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN">

<TITLE>Bridge Between NAICS and SIC: Manufacturing</TITLE>
<META http-equiv=Content-Type content="text/html; charset=windows-1252">
<META content="MSHTML 6.00.2900.3157" name=GENERATOR>

1997 Economic Census:
Bridge Between NAICS and SIC

Manufacturing

NAICS 339:
Miscellaneous mfg -   Finder by Major Group (2-digit SIC)

    Go to
bridge
    <A
<EMAIL_ADDRESS>    Description
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Estab-
lish-
ments
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Value of shipments
($1,000)
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Paid
employees
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Annual
payroll
($1,000)

    <A
<EMAIL_ADDRESS>      src="" border=0>
    339
    <A
<EMAIL_ADDRESS>      mfg
    31,554
    101,024,753
    735,337
    22,001,090

    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp19(1).tmp"
      border=0>
    3391
    <A
<EMAIL_ADDRESS>      equipment & supplies mfg
    12,702
    45,673,472
    297,019
    10,275,834

    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp19(1).tmp"
      border=0>
    3399
    <A
<EMAIL_ADDRESS>      miscellaneous mfg
    18,852
    55,351,281
    438,318
    11,725,256

NAICS 339:
Miscellaneous mfg -   6-digit NAICS by 4-digit SIC
Includes only establishments with payroll. <A
<EMAIL_ADDRESS>text includes scope and methodology. Figures to the left of SIC codes
indicate the percent of SIC receipts represented by that part; and link to Table
1 where other parts of the NAICS are shown.  links to 1997 and 1992
Comparative Statistics for whole SICs.

    <A
<EMAIL_ADDRESS>    <A
<EMAIL_ADDRESS>    <A
<EMAIL_ADDRESS>    Description
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Estab-
lish-
ments
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Value of shipments
($1,000)
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Paid
employees
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Annual
payroll
($1,000)

    3391

    <A
<EMAIL_ADDRESS>      equipment & supplies mfg
    12,702
    45,673,472
    297,019
    10,275,834

    33911

    <A
<EMAIL_ADDRESS>      equipment & supplies mfg
    12,702
    45,673,472
    297,019
    10,275,834

    339111

    <A
<EMAIL_ADDRESS>      apparatus & furniture mfg
    385
    2,471,153
    18,253
    686,742

    3821
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          apparatus & furniture

    385
    2,471,153
    18,253
    686,742

    339112

    <A
<EMAIL_ADDRESS>      & medical instrument mfg
    1,604
    18,512,172
    107,819
    4,156,387

    <A
<EMAIL_ADDRESS>      of
    3829
    20

<A
<EMAIL_ADDRESS>          & controlling devices, n.e.c. (pt)

    6
    62,148
    521
    17,287

    3841
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          & medical instruments

    1,598
    18,450,024
    107,298
    4,139,100

    339113

    <A
<EMAIL_ADDRESS>      appliance & supplies mfg
    1,652
    15,389,467
    85,315
    2,980,530

    <A
<EMAIL_ADDRESS>      of
    2599
    20

<A
<EMAIL_ADDRESS>          & fixtures, n.e.c. (pt)

    16
    645,688
    2,925
    115,475

    <A
<EMAIL_ADDRESS>    3842
    40

<A
<EMAIL_ADDRESS>          appliances & supplies (pt)

    1,636
    14,743,779
    82,390
    2,865,055

    339114

    <A
<EMAIL_ADDRESS>      equipment & supplies mfg
    877
    2,699,867
    18,072
    613,286

    <A
<EMAIL_ADDRESS>    3699
    85

<A
<EMAIL_ADDRESS>          equipment & supplies, n.e.c. (pt)

    0
    0
    0
    0

    3843
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          equipment & supplies

    877
    2,699,867
    18,072
    613,286

    339115

    <A
<EMAIL_ADDRESS>      goods mfg
    575
    3,607,813
    26,366
    814,242

    3851
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          goods

    575
    3,607,813
    26,366
    814,242

    339116

    <A
<EMAIL_ADDRESS>      laboratories
    7,609
    2,993,000
    41,194
    1,024,647

    8072
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          laboratories

    7,609
    2,993,000
    41,194
    1,024,647

    <A
<EMAIL_ADDRESS>    <A
<EMAIL_ADDRESS>    <A
<EMAIL_ADDRESS>    Description
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Estab-
lish-
ments
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Value of shipments
($1,000)
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Paid
employees
    <A
<EMAIL_ADDRESS>      face=Arial size=-1>Annual
payroll
($1,000)

    3399

    <A
<EMAIL_ADDRESS>      miscellaneous mfg
    18,852
    55,351,281
    438,318
    11,725,256

    33991

    <A
<EMAIL_ADDRESS>      & silverware mfg
    3,775
    8,523,365
    61,201
    1,535,238

    339911

    <A
<EMAIL_ADDRESS>      (except costume) mfg
    2,294
    5,422,634
    34,773
    886,562

    <A
<EMAIL_ADDRESS>      of
    3479
    20

<A
<EMAIL_ADDRESS>          coating & allied services (pt)

    22
    5,798
    79
    1,620

    3911
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>
          precious metal

    2,272
    5,416,836
    34,694
    884,942

    339912

    <A
<EMAIL_ADDRESS>      & plated ware mfg
    163
    905,980
    6,459
    187,166

    <A
<EMAIL_ADDRESS>      of
    3479
    30

<A
<EMAIL_ADDRESS>          coating & allied services (pt)

    12
    6,296
    103
    2,091

    <A
<EMAIL_ADDRESS>      of
    3914
    20

<A
<EMAIL_ADDRESS>          & plated ware (pt)

    151
    899,684
    6,356
    185,075

    339913

    <A
<EMAIL_ADDRESS>      material & lapidary work mfg
    394
    919,066
    5,396
    135,354

    3915
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          materials & lapidary work

    394
    919,066
    5,396
    135,354

    339914

    <A
<EMAIL_ADDRESS>      jewelry & novelty mfg
    924
    1,275,685
    14,573
    326,156

    <A
<EMAIL_ADDRESS>      of
    3479
    40

<A
<EMAIL_ADDRESS>          coating & allied services (pt)

    16
    2,257
    29
    663

    <A
<EMAIL_ADDRESS>    3499
    70

<A
<EMAIL_ADDRESS>          metal products, n.e.c. (pt)

    82
    49,953
    568
    10,912

    3961
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          jewelry

    826
    1,223,475
    13,976
    314,581

    33992

    <A
<EMAIL_ADDRESS>      & athletic goods mfg
    2,571
    10,591,160
    69,664
    1,831,218

    339920

    <A
<EMAIL_ADDRESS>      & athletic goods mfg
    2,571
    10,591,160
    69,664
    1,831,218

    3949
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          & athletic goods, n.e.c.

    2,571
    10,591,160
    69,664
    1,831,218

    33993

    <A
<EMAIL_ADDRESS>toy,
      & game mfg
    1,025
    4,834,318
    33,015
    837,181

    339931

    <A
<EMAIL_ADDRESS>&
      stuffed toy mfg
    240
    299,821
    3,393
    63,722

    3942
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>    240
    299,821
    3,393
    63,722

    339932

    <A
<EMAIL_ADDRESS>toy,
      & children's vehicle mfg
    785
    4,534,497
    29,622
    773,459

    <A
<EMAIL_ADDRESS>    3944
    20

<A
<EMAIL_ADDRESS>
          toys, & children's vehicles (pt)

    785
    4,534,497
    29,622
    773,459

    33994

    <A
<EMAIL_ADDRESS>      supplies (except paper) mfg
    1,038
    4,338,456
    30,138
    790,191

    339941

    <A
<EMAIL_ADDRESS>&
      mechanical pencil mfg
    112
    1,590,770
    8,394
    261,580

    3951
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          & mechanical pencils

    112
    1,590,770
    8,394
    261,580

    339942

    <A
<EMAIL_ADDRESS>pencil
      & art good mfg
    173
    1,234,456
    7,990
    195,586

    <A
<EMAIL_ADDRESS>      of
    2531
    30

<A
<EMAIL_ADDRESS>          building & related furniture (pt)

    17
    110,985
    941
    27,255

    <A
<EMAIL_ADDRESS>    3579
    30

<A
<EMAIL_ADDRESS>          machines, n.e.c. (pt)

    13
    257,020
    1,234
    30,572

    <A
<EMAIL_ADDRESS>      of
    3952
    30

<A
<EMAIL_ADDRESS>          pencils & art goods (pt)

    143
    866,451
    5,815
    137,759

    339943

    <A
<EMAIL_ADDRESS>      device mfg
    634
    643,007
    7,831
    185,316

    3953
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          devices

    634
    643,007
    7,831
    185,316

    339944

    <A
<EMAIL_ADDRESS>      paper & inked ribbon mfg
    119
    870,223
    5,923
    147,709

    3955
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          paper & inked ribbons

    119
    870,223
    5,923
    147,709

    33995

    <A
<EMAIL_ADDRESS>      mfg
    5,709
    7,910,809
    82,956
    2,382,461

    339950

    <A
<EMAIL_ADDRESS>      mfg
    5,709
    7,910,809
    82,956
    2,382,461

    3993
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          & advertising displays

    5,709
    7,910,809
    82,956
    2,382,461

    33999

    <A
<EMAIL_ADDRESS>other
      miscellaneous mfg
    4,734
    19,153,173
    161,344
    4,348,967

    339991

    <A
<EMAIL_ADDRESS>
      packing, & sealing device mfg
    665
    5,260,955
    42,166
    1,296,725

    3053
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>
          packing & sealing devices

    665
    5,260,955
    42,166
    1,296,725

    339992

    <A
<EMAIL_ADDRESS>      instrument mfg
    576
    1,356,651
    13,411
    363,022

    3931
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          instruments

    576
    1,356,651
    13,411
    363,022

    339993

    <A
<EMAIL_ADDRESS>
      button, needle, & pin mfg
    251
    828,918
    7,842
    206,148

    <A
<EMAIL_ADDRESS>    3131
    30

<A
<EMAIL_ADDRESS>          cut stock & findings (pt)

    2
    D
    (1-19)
    D

    3965
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>
          buttons, needles, & pins

    249
    D
    (5000-9999)
    D

    339994

    <A
<EMAIL_ADDRESS>
      brush, & mop mfg
    332
    2,024,389
    16,826
    435,792

    <A
<EMAIL_ADDRESS>      of
    2392
    30

<A
<EMAIL_ADDRESS>
          n.e.c. (pt)

    58
    321,250
    2,944
    63,782

    3991
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          & brushes

    274
    1,703,139
    13,882
    372,010

    339995

    <A
<EMAIL_ADDRESS>      casket mfg
    177
    1,271,184
    6,962
    212,491

    3995
    <A
<EMAIL_ADDRESS>      src="Q:\304m\Record\Electronic Project File\OW-2006-0771\04507_files\ftp1A(1).tmp"
      border=0>

<A
<EMAIL_ADDRESS>          caskets

    177
    1,271,184
    6,962
    212,491

    339999

    <A
<EMAIL_ADDRESS>other
      miscellaneous mfg
    2,733
    8,411,076
    74,137
    1,834,789

    <A
<EMAIL_ADDRESS>      of
    2499
    50

<A
<EMAIL_ADDRESS>          products, n.e.c. (pt)

    449
    1,227,261
    13,740
    270,999

    <A
<EMAIL_ADDRESS>    3999
    80

<A
<EMAIL_ADDRESS>          industries, n.e.c. (pt)

    2,284
    7,183,815
    60,397
    1,563,790

N=Not available D=Withheld to
avoid disclosure

=sum of SIC parts listed below the
symbol

    (Bridge complete.)
    Comparable
    NAICS derivable from SIC data.

    (Drawbridge slightly open.)
    Almost comparable
    Sales or receipts from SIC are within 3% of NAICS sales
      or receipts.

    (Drawbridge open.)
    Not comparable
    NAICS sales or receipts cannot be estimated within 3%
      from SIC data.

    <A
<EMAIL_ADDRESS>      menu and index
    <A
<EMAIL_ADDRESS>      NAICS menu
    <A
<EMAIL_ADDRESS>      in formats for downloading
    <A
<EMAIL_ADDRESS>      report

Source: 1997
Economic Census, Comparative Statistics

Last modified: 7/19/00

<A
title="Skip Navigation"
<EMAIL_ADDRESS>this navigation

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[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Notices]
[Page 34338]
[DOCID:fr14jn06-75]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2485-033, Massachusetts]

Northeast Generation Company; Notice of Availability of
Environmental Assessment

June 7, 2006.
    In accordance with the National Environmental Policy Act of 1969,
as amended, and the Federal Energy Regulatory Commission's (Commission)
regulations (18 CFR part 380), Commission staff have reviewed the
application, filed May 12, 2006, by the project licensee, Northeast
Generation Company, for a temporary amendment of license for the
Northfield Mountain Pumped Storage Project. The request is for a
deviation from required project operating limits to allow additional
operating flexibility this summer. The project is located on the east
side of the Connecticut River, in the towns of Northfield and Erving,
in Franklin County, Massachusetts.
    The proposal would modify the upper reservoir's water surface
elevation limits from 938 and 1000.5 feet mean sea level (msl), to 920
and 1004.5 feet msl, respectively, and allow a maximum daily generation
of 10,465 megawatt hours (MWh) under certain ISO-NE emergency operating
conditions from June 3, 2006, through September 30, 2006. At all other
times, the upper reservoir would be operated within existing limits,
and generation would be within the existing maximum limit of 8,475 MWh.
The project uses the reservoir at the Turners Falls Project (FERC No.
1889) on the Connecticut River as its lower reservoir, and proposes no
changes in its operating elevations.
    In the environmental assessment (EA), Commission staff has analyzed
the probable environmental effects of the proposed amendment and has
concluded that approval, with the addition of staff-recommended
measures, would not constitute a major Federal action significantly
affecting the quality of the human environment.
    A copy of the EA is attached to the Commission order titled ``Order
Granting Temporary Amendment of License,'' issued June 7, 2006, and is
available at the Commission's Public Reference Room. A copy of the EA
may also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``elibrary'' link. Enter the docket number (P-2485) in the
docket number field to access the document. For assistance, call (202)
502-8222, or<PHONE_NUMBER> (for TTY).

Magalie R. Salas,
Secretary.
[FR Doc. E6-9294 Filed 6-13-06; 8:45 am]

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[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Rules and Regulations]
[Pages 71016-71017]
[FR Doc No: 2010-29326]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526

[Docket No. FDA-2010-N-0002]

Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplementary new animal drug
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The
supplement provides for minor revisions to labeling.

DATES: This rule is effective November 22, 2010.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002 has filed a supplement to
NADA 55-058 for DRY-CLOX (cloxacillin benzathine) Intramammary Infusion
for dry dairy cattle. The supplemental NADA provides for various minor
revisions to labeling. The supplemental application is approved as of
October 21, 2010, and the regulations in Sec.  526.464a (21 CFR
526.464a) are amended to reflect the approval.
    In addition, FDA has noticed that certain portions of Sec.
526.464a were inadvertently removed when the regulations were amended
to reflect a change of sponsorship (75 FR 10165, March 5, 2010). At
this time, the regulations are being amended to reflect fully the
approved conditions of use of this new animal drug product. This change
is being made to improve the accuracy of the animal drug regulations.
    Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required. The Agency has
determined under 21 CFR 25.33 that this action is of a type that does
not individually or cumulatively have a significant effect on the human
environment. Therefore, neither an environmental assessment

nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 526

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 526 is
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 526 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise the heading for part 526 to read as set forth above.

0
3. In Sec.  526.464a, revise paragraph (c) to read as follows:

Sec.  526.464a  Cloxacillin benzathine.

* * * * *
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for
use in dairy cows.
    (1) Amount. Administer aseptically into each quarter immediately
after last milking.
    (2) Indications for use. For the treatment of mastitis caused by
Staphylococcus aureus and Streptococcus agalactiae including penicillin
resistant strains in dairy cows during the dry period.
    (3) Limitations. For use in dry cows only. Not to be used within 30
days of calving. Animals infused with this product must not be
slaughtered for food use for 30 days after the latest infusion. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.

    Dated: November 16, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-29326 Filed 11-19-10; 8:45 am]
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