Free Supplemental Brief - District Court of Federal Claims - federal

Case 1:05-cv-01179-MBH

Document 28-3

Filed 09/27/2006

Page 1 of 2
8279

RULES AND REGULATIONS

,.::'~ Area of inte.rna.l standard peak '
::,:-Ûea of internal standard peak " .
,~Àrea. of t~eclil'~amycin i'itandard peak;

,',,',i\a arved for the clindamycin standard) .

'i f the clindamycin sample peak (at a retention time equal to that

abse .
Millgrams of clmdamycIl per capsUle=-RsXW~'

.' RuXWsX/XWa

(c) Amendments to the regulations or new regulations wil be published in the
FEDERAL REGISTER. The effective date

wil be not less than 30 days after the
date of publication except when otherwise provided by the Administrative Procedure Act.
amended, sec. 633, 63 stat. 545, sec. 2, 23 Stat. 118, as amended, RS. 4405, as amended, RS. 4462, as amended, sec. 6, 80 Stat. 947; 5, U.S.C.
553, 14 U.S.C. 2, 633, 46 U.S.C. 2, 375, 416, 49

(Sec. 553, 80 Stat. 383, sec. 2, 63 Stat. 496, as

:'weight of clindamycii; worki..g standa,rd in milligrams; Ie weight in mill,grams, , ~:~cy of clindamycin working standard in millgrams of 'Clindamycin pel'

:: millgram: ... .
, Avera:ge capsule fill weight II mmlligrams.

U.S.C.1655; 49 CFR 1.4 (a) and (g))

Effective date. This amendment shall

oisture. Prcceed as directed in tion and this redelegation by the Comma.ndant to Chief, Offce of Operations,
upplied by the manu~acturer

become effective upon publication in the
FEDERAL REGISTER.

of this chapter.

a the subject antibiotic drugs
of these drugs have been
with and since it is in the

"evaluated. Since the condi-

agency organization and management, they are excepted from the public rulerequirement of the Administrative Procedure Act. 1. Section 1.05-1 is revised to read as

Since the revised sections deal with

Dated: May 20, 1970.
W. J. SMITH,

'equisite to providing for cer-

making prccedmes and the effective date

Admiral, U.S. Coast Guard,
8:49 a.m.) ,

. Commandant.

(F.R. Doc. 70-6548; Filed, May 26, 1970;

. terest not to delay in so pronotice and public procedure a~d

follows;
§ 1.05-1 General. (a) The Secretary of Transportation
SUBCHAPTER J-BRIDGES

'ëffective date are not prerequuthis promulgation.

ive date. This order shall be
'upon publication in the FEDSTER.

regulations regarding the functions,
powers and duties of the Coast Guard.

is empowered by various statutes to issue
(b) The Secretary of Transportation

(COFR 70-28aJ

PART 117-DRAWBRIDGE
OPERATION REGULATIONS

'7, 59 Stat. 463, as amended; 21
7)

: May 15,1970.

SAM D. FINE,

Assochte Commissioner for Compliance.
70-6510; Filed, May 26, 1970;
8:45 a.m.)

33-NA¥~~ATmN AN~
NAVIGABLE WATERS
!~J-Coast GIJ!Cud, Depcn\'meldt

Sabine River, Texas by 49 CFR 1.45 and 1.46 has delegated to the Commandant, U.S. Coast Guard, 1. The Livingston Shipbuilding Ca. by the authority to issue regulations regard- letter dated November 24, 1969, requested ing the functions, powers and duties of the Commander, Eighth Coast Guard the Coast Guard together with the au- District to provide special operation reguthority to redelegate and authorize suc- lations for its swing span pontoon bridge cessive redelegations of that authority across Sabine River (Old Channel) bewithin the Coast Guard. hind Orange Harbor Island. at Orange, (c) The Commandant redelegates to Tex. A public notice dated December 18, the Chief, Offce of Operations, U.S. 1969, setting forth the proposed revision Coast Guard Headquarters with the res- of the regulations governing this drawervation that this authority shall not bridge was issued by the Commander,
be further redelegated the authority to

:.:¡'. of TrClns¡co.tcHon
. SUBCHAPTER A-GENERAL
. , (CGF'R 69-115 J

issue rules and regulations pertaining to made available to all persons known to have an interest in this subject. The (1) The establishment and disestab- Commandant also published these prolishment of anchorage grounds ¡;nd spe- posals in.the FEDERAL REGISTER of March cial anchorage areas. 24, 1970 (35 F.R. 5012). (2) Changes to the anchorage regula2. After consideration of all known tions.

the following: '

Eighth Coast Guard District and was

I-GENERAL P¡lOV¡SIONS

part 1.05-ihlle Making
ELEGATION OF AUTHORI1".l

(3) The affrmance of the actions of fractors in this case this proposal is CFR 117.245(j) the Coast Guard District Commanders accepted. Accordingly, 33 read as follows: (25-a) is added and shall
concerning security zones.
as follows: § 1.05-30 Final action.
date when comments may be submitted
2. Section 1.05-30 is revised to read

§ 117.245 Navigable waters discharging

e policy of the Department of

ion of authority to the maxient Compatible with effective
and control. In consonance

.tion to provide for the de-

into the Atlantic Ocean south of and including Chesapeake Bay and into
the Gulf of Mexico, except the Mis-

(a) After the hearing or after the final

, sissippi River and its tributaries and outlets; bridges where constimt attendance of draw

,lOUey, the CommandantOperato the Chief, Offce of has re-

posed rulemaking, the Merchant Marine Council or the offcial designated in the
notice shall consider all the data, views

in accordance with the notice of pro-

tenders is not

required.

't'Oh (l the establishmentperrrty to issue regulations and

h~" Coast. Guard Headquarters

ward to the appropriate offcer recom-

.aneh '

/ anchorage areas (2) changes

!~l ment of anchorage grounds

ce orage regulations, and (3) . er concerning security zones. '.' d of the actions of District
iL~ent by revision of § § 1.05-1

through Friday, except holidays. At all (b) Final action on the proposed regulation wil be determined and the regu- other times, including legal holidays, 8lation wil be issued by the Commandant,
hours' advance notice is required.
u.s. Coast Guard, or by the Chief, Offce

(26-a) Sabine River (Old Channel) behind Orange Harbor Island, Orange, Tex. mendations regarding the proposed regu- The draw shall be opened promptly on signal from 7 a.m. to 12 Midnight Monday lations.

or arguments submitted and shall for-

-(j) . . .

ùa' reflects the transfer of the
'thred6rom the Treasury DepartePartment of Transporta-

of Operations, U.S. Coast Guard Headquarters within the limits of the authority redelegated to him by § 1.05-1(c).

(Sec. 5, 28 Stat. 362, as amended, sec. 6(g) (2),
80 Stat. 937; 33 U.S.C. 499, 49 U.S.C. 1655(g)

(2); 49 CFR 1.46(c) (5) )

FEDERAL REGISTER, VOL. 35, NO. 103-WEDNESDAY, MAY 27, 1970

Defendant's Exhibit 5

Case 1:05-cv-01179-MBH
8280

Document 28-3

Filed 09/27/2006

Page 2 of 2

RULES AND REGULA nONS

ment or modifcation of harbor l Effective date. This reviion shall be- solid fil construction shOl'èward' ofes- through the appropriate Division En tablished harbor lines without obtaining come effective 30. days following the date a permit under 33 U.S.C. 403. This was a neer to the Chief of Engineers, ENGC of publication in the FEDERAL REGISTER. . matter of great concern, particularly iñ ON. No new harbor lines wil be est Dated: May 20, 1970. cases involving long established harbor lished and no existing harbor lines Vi lines, since all factors affecting the pub- be modified uness specifcally authoriz' W'. J. SMITH, taken into by the Chief of Engineers. . lic interest may not have been
Admiral, U.S. Coast Guard, Commandant.
8:49 a.m.l
account at :the time

the lines were estab-

(Regs., ENGCW-ON) (Sees. 10
Stat. 1151: 33 U.S.C. 403, 404)

lished. Accordingly, under previous

(F.R. Doc. 70-6549; FÚed, May 26, 1970;

. policies, practices and procedures there
was the danger that work shoreward of

For the Adjutant GeneraL

(CGFR 70-7o. without appropriate consideration havOPERA..TlON REGULATIONS 'without a judgment having been made

existing harbor lines could be undertaken

RICHARD B. BELNAP

Special Ad~isor to T ÂG
¡F.R. Doc. 70-6534: Filed, May 26, 19

PART 117-DRAWBRIDGE ing 'been may havethe impact which such work given to on the environment and

8:48 a.m.) . ..:',,"",

:::y~I;~;J.(

, Removed Bridges balance, in the publlc interest. . ' (2) In order to assure that the

Revocation of Regulations for as to. wh~ther or no.t the work was, on
public

Title 47- TELECOMMUNICA TlON:~1!r¡;\

1. The Commandant has been advised interest'wil be 'considered and protected that the Washington street bascule in all instances all existing and future bridge across the Petaluma River at harbor lines a;e declared to be guidePetaluma, Calif., for which special opera- lines for defining with respect to the

Chapter I-Federal Communicaticìri~/;':,:t
(FCC 70-533)

Commission . "'"7';';;': '. ';\;~:~~~.:
::.;,(::i" ,/".:~',~i, ~;;'. :':::~:!l~Y

tion regulations had been presci:ibed, has impact.. on navig~tion interests alone,
been removed and these regulations gov- - the offshore limits of open pile struc-

PART O-COMMISSION
ORGANIZATION

quured. head lines). A permit under 33 U.S.C. (g) (2) 403 will be required in each case for any
2. Accordingly, 33 CFR 117.712 is revied'

en,ng its operation are. no longer, re- tures (pie.rhead lines) ,or fils (bulk-.
to read as follows: work which is commenced shorewârd
*

Requests for Ins1pection of Materials';;;';:
Not Ro~tinely Available for pubíi~,~¡;¡ti

§ 117.712 Tributaries of San Francisco of existing or future harbor lines after
Bay and San Pablo Bay, Calif. the date of publication of this, regula*

Inspection "',::;;,1

ings of the of Petalumahighway brige be fied and processed in accordance with proceeding presidig offcer in a hear.g,0j"; involving the inpeion9f/.! at "D" Street. At least 6-hours' advance the provisions of applicable sections of Commission records. We have deter~èi~ notice required. this part. For work already completed
(2) City

(g) * * *

tion in the FEDERAL REGISTER. Applications for permits for work in navigable waters shoreward of harbor lines shal

rues and regulations now provides for)".
app~a! 1;" the L;vmmssion from the ruI",,':i;j

Orde~. 1. Secti~n 0..461(eH3) of thi'::Mf1

*

*

or commenced in conformance with
existing harbor line authority before
that date, 'no permit is required.

mined to amend this section to provide;';¡ for appeal to the Review Board rathèr,;)J,
than the Commssion. It a general matter that such appels

(Sec. 5, 2B Stat. 362, as amended, sec. 6(g) (2),
BO Stat. 937; 33 U.S.C. 499, 49 U.S.C. 1655(g)
(2); 49 CFR 1.6

is desirable~:;,;j
be",.,!

(c) (5) )

. (c) Establishment or modification of

Effective date. This. revision shaIl. become effective 30. days following the date
of publication in the FEDERAL REGISTER.

harbor lines. Applications for the establishment of new harbor lines or the mod-

handled by the Board, in the Saaë"Z;'j
manner as other appeals from ruins of.;¡
the presiding offcer, and it is our be1iefX~

Dated: May 20., 1970..
W. J. SMITH,

ifcation of existing harbor lines wil be processed in a manner similar to applications for permits for work in navigable waters. Public notices concerning

that the change wil expedite their;CJ

consideration. ' ,0 ,.,..
2. Authority for the adoption of

Admiral, U.S. Coast Guard, Commandant.
(F.R. Doc. 70-6550; Filed, May 26, 1970;
8:49 a.m.)

any such application wil be sent to all parties known or believed to be interested in the application and a copy of
the notice wil be posted in post offces

amendment is contained in sections 4(i)'C"d¡'¡
5(d), and 30.3(1') of the communcations;);;!"

Act of 1934, as amended, 47 U.S.C. 154(i);':~~ 155 (d), and 303 (1') . Because the amend,.;,~,;!"

Chapter II-Corps of Engineers,

Departmel1t of the Army
PART 209-ADMINISTRATIVE
PROCEDURE

notices, apart from providing inorma- organzation, the prior notice and effE)~:i:)::~ tion relative to any harbor line applica- tive date provisions of 5 U.S.C. 553 do np~.~i~i tion, shall make it clear that harbor' lines are guidelines for defiing, with 3. In view of the foregoing: It'is:'!ìj'

or other public places in the area. Public

ment relates to matters of practic~ ~d",.,I,N
procedure and to internal Comms10n:;.¡¡

apply. ,',' ');:
ordered, Eíective June I, 1970, That;:~t
lO68, 1082; ~7 U.S.q. 154, 155, 303):',.,".,,;;t\i:,,'

respect to the impact on navigation
open pile structures or fis

interests alone, the offshore limits of

.. Harbor Lines
10. and 11 of the River and Harbor Act
Pusuant to the provisions of sections

§ O.46He) (3 is as set fort"éj and that the below. Appeals no:" revised wil be acte,?:,,;i':J on hand

esta;blishment of a harbor line carries with it no presumption that individual applications for permits to undertake

on under the revved procedure. if;~j

(See. 4, 5, 303, 4B Stat., as amended, 1066;/;tl,

of Mãrch 3,1899 (30 Stat. 1151;33 U.S.C. work shoreward of any harbor line wil 40.3, 40.4), § 209.150. is hereby amended in . be granted. Public hearings will be held its entirety effective upon publication in connection with applications for the establishment or modifcation of harbor in the FEDERAL REGISTER as foIlows: lines whenever there appears to be sUf§ 209.150 Harbor lines. cient public interest to justify the hold-

Adopted. May 20., 1970..,i¡.!, ". .~',,~;. Releas~: May 22,1970.. ,.,Cia . ':;,¡_..~
FEDERAL COMMCATIONS'!i¡ì

COMMISSION ,ti~

(a) Definition. The term "harbor line
(s)" is used here in its generic sense.

ingof a public hearing or when respon-'

(SEAL) BEN F. WAPLE, ""',','.,.,',',,',,,,','.,',",',',','",'.,.,'j,

It includes types of harbor lines fre- including Members of the Congress, reIn Part 0' of Chapter I of Title 47 ofth~/;g quently referred to by other names, in- quest that a hearing be hela ami it is Cod: of ~ederal Reguations, § 0.46¡(e!i,;i likely that information wil be presented
cludig, for example, pierhead lines and

. sible Federal, State or local authorities,

Secretary.''''j

bulkhead lines.

(b) Policies, practices and procedures. in determining whether the harbor line § 0.461 Requests for inspection of JIfa"/;;J¡ terials not routinely available o~(¡¡ ( 1 ) Under previous policies, practices should be established or modified. Disand procedures, riparian owners could trict Engineers wil forward all recomerect open pile structures, or undertae mendations concerning the establish-

at the hearing that wil be of assistance

(3) isreVlsed to read as fOllows:::,;;¡

;ublic ~spectiO:. :i,j

1.5,~ =:

FEDERAL REGISTER, VOL. 3S, NO. 103-WEDNESDAY, MAY 27, 1970

!