alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
[Federal Register Volume 76, Number 2 (Tuesday, January 4, 2011)]
[Notices]
[Page 368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33210]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0373]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Preparing a Claim of Categorical 
Exclusion or an Environmental Assessment for Submission to the Center 
for Food Safety and Applied Nutrition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Preparing a Claim of Categorical 
Exclusion or an Environmental Assessment for Submission to the Center 
for Food Safety and Applied Nutrition'' has been approved by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 
1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850. 301-796-3793.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 
2010 (75 FR 59722), the Agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. 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. OMB has now approved the 
information collection and has assigned OMB control number 0910-0541. 
The approval expires on December 31, 2013. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: December 27, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-33210 Filed 1-3-11; 8:45 am]
BILLING CODE 4160-01-P
§ 123.5 Current good manufacturing practice. ( a ) Except as provided by § 117.5(b), parts 110 and 117 of this chapter apply in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary conditions.
( b ) The purpose of this part is to set forth requirements specific to the processing of fish and fishery products.
[60 FR 65197, Dec. 18, 1995, as amended at 80 FR 56167, Sept. 17, 2015]
Insignia Commercial
                            Investments Group, Inc.

October 7, 1997

Factory Outlet Centre Limited Liability Company
c/o The Balcor Company
Bannockburn Lake Office Plaza
2355 Waukegan Road
Suite A-200
Bannockburn, Illinois  60015

     Re:  Agreement of Sale dated as of August 25, 1997 between Insignia 
          Commercial Investments Group, Inc. ("Purchaser") and Factory Outlet 
          Centre Limited Liability Company ("Seller") for the purchase and sale
          of property known as the Factory Outlet Center in Kenosha, Wisconsin 
          ("Property") as amended by September 8, 1997 Letter Agreement

Dear Madam or Sir:

     Under the above referenced Agreement of Sale, the Purchase Price (as
defined herein) is $17,000,000, the Inspection Period, as defined therein,
expires on October 8, 1997 and the Closing Date, as defined therein, was set to
be November 12, 1997.

     This letter shall confirm that Seller has, among other things, agreed to
provide Purchaser with additional time to conduct investigations and studies of
the Property, and to attempt to finalize an agreement with one of the
Purchaser's equity partners.  It shall be at Purchaser's sole discretion,
whether to elect to purchase the Property, or to terminate the Agreement of
Sale, as provided in Article 7 thereof.

     The Purchase Price shall be revised to read $15,000,000, the Inspection
Period shall be revised to end at 5:00 p.m. Chicago time on November 8, 1997
and the Closing Date shall be revised to be on December 8, 1997.

     Except as provided herein, the Agreement of Sale shall remain unmodified
and in full force and effect.

     If the amendments to the Agreement of Sale provided in this letter are
acceptable, please indicate your agreement on behalf of Seller, where indicated
below.

                         Sincerely,

                         /s/ Michael R. Horowitz
                         Michael R. Horowitz
                         President
<PAGE>
Agreed and Accepted this 7th day of October, 1997

Factory Outlet Centre Limited Liability Company

By: Outlet Centre Investors, a member

     By:  Balcor Partners-XXI, its general partner

          By: /s/ Beth Goldstein
              ------------------------------
          Name:   Beth Goldstein
          Its:    Authorized Representative
<PAGE>
§ 1004.4 Plans for refunding the cost of electronic products. Every plan for refunding the cost of an electronic product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include: ( a ) Identification of the product involved.
( b ) The approximate number of defective product units which have left the place of manufacture.
( c ) The manner in which the refund operation will be effected including the procedure for obtaining possession of the product for which the refund is to be made.
( d ) The steps which the manufacturer will take to insure that the defective products will not be reintroduced into commerce, until it complies with each applicable Federal standard and has no defect relating to the safety of its use.
( e ) A time limit, reasonable in light of the circumstances, for obtaining the product and making the refund.
( f ) A statement that the manufacturer will refund the cost of such product together with the information the manufacturer has used to determine the amount of the refund.
( g ) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons; ( 1 ) That the manufacturer, at his expense, will refund the cost of the electronic product plus any transportation costs,
( 2 ) Of the amount to be refunded exclusive of transportation costs,
( 3 ) Of the method by which the manufacturer will obtain possession of the product and make the refund.
( h ) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of refunds made.
II 

109TH CONGRESS 

1ST SESSION S. 1083 

To provide coverage under the Railway Labor Act to employees of certain 

air and surface transportation entities. 

IN THE SENATE OF THE UNITED STATES 

MAY 19, 2005 

Mr. HARKIN introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide coverage under the Railway Labor Act to 

employees of certain air and surface transportation entities. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Express Carrier Em5 ployee Protection Act’’. 

6 SEC. 2. AMENDMENT TO THE RAILWAY LABOR ACT. 

7 Section 201 of the Railway Labor Act (45 U.S.C. 

8 181) is amended— 

9 (1) by striking ‘‘All’’ and inserting ‘‘(a) IN

10 GENERAL—All’’; 
2 

S 1083 IS

1 (2) by inserting ‘‘and every express carrier’’ 

2 after ‘‘common carrier by air’’; and 

3 (3) by adding at the end the following: 

4 ‘‘(b) EXPRESS CARRIERS.—The employees of an ex5 press carrier shall be covered by this Act only if they are 

6 licensed airmen, licensed aircraft maintenance technicians, 

7 or licensed aircraft dispatchers, and only if they perform 

8 duties for the express carrier pursuant to the privileges 

9 of the appropriate license. All other employees of an ex10 press carrier shall be covered by the provisions of the Na11 tional Labor Relations Act. 

12 ‘‘(c) DEFINITION.—In this section, the term ‘express 

13 carrier’ means any company (or companies affiliated 

14 through common control or ownership) that has an inte15 grated network of air and surface transportation for the 

16 purpose of the express shipment of packages.’’. 

Æ
§ 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do? ( a ) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria: ( 1 ) The HCT/P is minimally manipulated;
( 2 ) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
( 3 ) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
( 4 ) Either: ( i ) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
( ii ) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and: ( a ) Is for autologous use;
( b ) Is for allogeneic use in a first-degree or second-degree blood relative; or
( c ) Is for reproductive use.
( b ) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section: ( 1 ) You must register with FDA;
( 2 ) You must submit to FDA a list of each HCT/P manufactured; and
( 3 ) You must comply with the other requirements contained in this part.
[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]
```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 112 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  1st Session
                                 S. 112

 To amend title 38, United States Code, to authorize per diem payments 
 under comprehensive service programs for homeless veterans to furnish 
    care to dependents of homeless veterans, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            January 12, 2017

Mr. Heller (for himself and Mrs. Murray) introduced the following bill; 
which was read twice and referred to the Committee on Veterans' Affairs

_______________________________________________________________________

                                 A BILL

 
 To amend title 38, United States Code, to authorize per diem payments 
 under comprehensive service programs for homeless veterans to furnish 
    care to dependents of homeless veterans, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Creating a Reliable Environment for 
Veterans' Dependents Act''.

SEC. 2. AUTHORIZATION OF PER DIEM PAYMENTS FOR FURNISHING CARE TO 
              DEPENDENTS OF CERTAIN HOMELESS VETERANS.

    Section 2012(a) of title 38, United States Code, is amended by 
adding at the end the following new paragraph:
    ``(4) Services for which a recipient of a grant under section 2011 
of this title (or an entity described in paragraph (1)) may receive per 
diem payments under this subsection may include furnishing care for a 
dependent of a homeless veteran who is under the care of such homeless 
veteran while such homeless veteran receives services from the grant 
recipient (or entity).''.
                                 <all>
```
§ 111.320 What requirements apply to laboratory methods for testing and examination? ( a ) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
( b ) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.
§ 1240.10 Effective bactericidal treatment. Whenever, under the provisions of this part, bactericidal treatment is required, it shall be accomplished by one or more of the following methods: ( a ) By immersion of the utensil or equipment for at least 2 minutes in clean hot water at a temperature of at least 170 °F or for one-half minute in boiling water;
( b ) By immersion of the utensil or equipment for at least 2 minutes in a lukewarm chlorine bath containing at least 50 ppm of available chlorine if hypochlorites are used or a concentration of equal bactericidal strength if chloramines are used;
( c ) By exposure of the utensil or equipment in a steam cabinet at a temperature of at least 170 °F for at least 15 minutes or at a temperature of 200 °F for at least 5 minutes;
( d ) By exposure of the utensil or equipment in an oven or hot air cabinet at a temperature of at least 180 °F for at least 20 minutes;
( e ) In the case of utensils or equipment so designed or installed as to make immersion or exposure impractical, the equipment may be treated for the prescribed periods of time either at the temperatures or with chlorine solutions as specified above, ( 1 ) with live steam from a hose if the steam can be confined,
( 2 ) with boiling rinse water, or
( 3 ) by spraying or swabbing with chlorine solution;
( f ) Any other method determined by the Commissioner of Food and Drugs, upon application of an owner or operator of a conveyance, to be effective to prevent the spread of communicable disease.
[40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989]
IN THE UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF ALABAMA

NORTHERN DIVISION

UNITED STATES OF AMERICA )

)

vs. ) Case No. 2:06CR206-MHT

)

ALETHIA ADRIANNE SCOTT )

PRETRIAL CONFERENCE ORDER

A pretrial conference was held on September 25, 2006 before the undersigned

Magistrate Judge. Present at this conference was the Honorable Donnie Bethel, counsel

for the defendant, and Assistant United States Attorney Christopher Snyder, counsel for

the government. As a result of the conference, it is

ORDERED as follows:

1. Jury selection is set for October 30, 2006. The trial of this case is set for the

trial term commencing on October 30, 2006 before United States District Judge Myron

H. Thompson and is expected to last two (2) trial days.

2. There are no motions currently pending.

3. Proposed voir dire questions shall be filed on or before October 23, 2006.

Counsel should not include questions seeking information which is provided in the jury

questionnaire.

4. All Motions in Limine shall be filed on or before October 23, 2006. Motions in

Limine must be accompanied by a brief. Failure to file a brief will result in denial of the

motion.

Case 2:06-cr-00206-MHT-CSC Document 38 Filed 09/26/2006 Page 1 of 2
5. Proposed jury instructions shall be filed on or before October 23, 2006.

6. The court will not consider a plea pursuant to Rule 11(c) (1)(A) or (C) unless

notice is filed on or before noon on October18, 2006. The government and defendant

are informed that if a defendant waits until the last minute to enter a plea, and if that plea,

for whatever reason, is not accepted by the court, the defendant and the government will

be expected to be prepared to go to trial on October 30, 2006. The court will not

continue the trial of this case as to any defendant because a defendant’s plea was not

accepted. In other words, the defendant and the government should not wait until the last

minute for a defendant to enter a guilty plea, and both the defendant and the government

should all be ready to go to trial on October 30, 2006, as to all defendants, even though a

particular guilty plea was not accepted by the court.

Done this 26 day of September, 2006. th

 /s/Charles S. Coody 

CHARLES S. COODY

CHIEF UNITED STATES MAGISTRATE JUDGE

Case 2:06-cr-00206-MHT-CSC Document 38 Filed 09/26/2006 Page 2 of 2
```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 991 Introduced in House (IH)]

109th CONGRESS
  2d Session
H. RES. 991

 Congratulating the Columbus Northern Little League Baseball Team from 
   Columbus, Georgia, on its victory in the 2006 Little League World 
                       Series Championship games.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 7, 2006

Mr. Westmoreland (for himself, Mr. Bishop of Georgia, Mr. Gingrey, Mr. 
 Kingston, Mr. Marshall, Ms. McKinney, Mr. Lewis of Georgia, Mr. Price 
 of Georgia, Mr. Linder, Mr. Norwood, Mr. Deal of Georgia, Mr. Barrow, 
 Mr. Scott of Georgia, Mr. Peterson of Pennsylvania, and Mr. Sherwood) 
submitted the following resolution; which was referred to the Committee 
                          on Government Reform

_______________________________________________________________________

                               RESOLUTION

 
 Congratulating the Columbus Northern Little League Baseball Team from 
   Columbus, Georgia, on its victory in the 2006 Little League World 
                       Series Championship games.

Whereas on Monday, August 28, 2006, the Columbus Northern Little League baseball 
        team from Columbus, Georgia, defeated the Japanese Little League team by 
        a score of 2-1 to win the 2006 Little League World Series Championship 
        at South Williamsport, Pennsylvania;
Whereas, although Columbus Northern had taken 1 loss in the series, they did not 
        give up, and although the Championship game was delayed a day by rain, 
        the Columbus Northern team still kept pressing hard to come from behind 
        to win the Championship game;
Whereas a team from the State of Georgia had not won the world title in more 
        than 20 years;
Whereas the 2006 Columbus Northern Little League World Championship team 
        consists of players Kyle Carter, Brady Hamilton, Matthew Hollis, Matthew 
        Kuhlenberg, Josh Lester, Ryan Lang, Mason Meyers, J.T. Phillips, Kyle 
        Rovig, Patrick Stallings, and Cody Walker;
Whereas the 2006 Columbus Northern Little League World Championship team is led 
        by Coach Richard Carter, Manager Randy Morris, Team Mother Lynne 
        Phillips, and President Curt Thompson;
Whereas the championship victory of the Columbus Northern Little League Baseball 
        Team sets an example of sportsmanship, dedication, and a ``never give 
        up'' spirit for men and women all across the country; and
Whereas the achievement of the Columbus Northern Little League Baseball Team is 
        the cause of enormous pride for the Nation, the State of Georgia, and 
        the city of Columbus: Now, therefore, be it
    Resolved,  That the House of Representatives congratulates the 
Columbus Northern Little League Baseball Team from Columbus, Georgia, 
on its victory in the 2006 Little League World Series Championship 
games.
                                 <all>
```
§ 1271.400 Inspections. ( a ) If you are an establishment that manufactures HCT/Ps described in § 1271.10, whether or not under contract, you must permit the Food and Drug Administration (FDA) to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance with applicable provisions of this part. The inspection will be conducted as necessary in the judgment of the FDA and may include your establishment, facilities, equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and controls required to be maintained under the part. The inspection may be made with or without prior notification and will ordinarily be made during regular business hours.
( b ) The frequency of inspection will be at the agency's discretion.
( c ) FDA will call upon the most responsible person available at the time of the inspection of the establishment and may question the personnel of the establishment as necessary to determine compliance with the provisions of this part.
( d ) FDA's representatives may take samples, may review and copy any records required to be kept under this part, and may use other appropriate means to record evidence of observations during inspections conducted under this subpart.
( e ) The public disclosure of records containing the name or other positive identification of donors or recipients of HCT/Ps will be handled in accordance with FDA's procedures on disclosure of information as set forth in parts 20 and 21 of this chapter.
#### § 1240.45 Report of disease.

The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.
EXHIBIT 99.1

                            CERTIFICATION PURSUANT TO
                             18 U.S.C. SECTION 1350,
                             AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

     In connection  with the Quarterly  Report of National  Medical  Health Card
Systems,  Inc. (the "Company") on Form 10-Q for the period ending  September 30,
2002 as filed with the  Securities  and Exchange  Commission  on the date hereof
(the  "Report"),  I,  James J. Bigl,  Chief  Executive  Officer of the  Company,
certify,  pursuant to 18 U.S.C.  ss. 1350, as adopted pursuant to ss. 906 of the
Sarbanes-Oxley Act of 2002, that:

     (1) The Report fully  complies  with the  requirements  of section 13(a) or
15(d) of the Securities Exchange Act of 1934; and

     (2)  The  information  contained  in the  Report  fairly  presents,  in all
material  respects,  the  financial  condition  and result of  operations of the
Company.


 /s/ James J. Bigl

James J. Bigl
Chief Executive Officer
November 12, 2002


<PAGE>


                                                                 EXHIBIT 99.2

                            CERTIFICATION PURSUANT TO
                             18 U.S.C. SECTION 1350,
                             AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


     In connection  with the Quarterly  Report of National  Medical  Health Card
Systems,  Inc. (the "Company") on Form 10-Q for the period ending  September 30,
2002 as filed with the  Securities  and Exchange  Commission  on the date hereof
(the  "Report"),  I, David  Gershen,  Chief  Financial  Officer of the  Company,
certify,  pursuant to 18 U.S.C.  ss. 1350, as adopted pursuant to ss. 906 of the
Sarbanes-Oxley  Act of  2002,  that:  (1) The  Report  fully  complies  with the
requirements  of section 13(a) or 15(d) of the Securities  Exchange Act of 1934;
and (2) The information contained in the Report fairly presents, in all material
respects,  the financial condition and result of operations of the Company.

 /s/ David Gershen


David Gershen
Chief Financial Officer
November 12, 2002