datamatters24/research-document-archive huggingface dataset:
200 
‘‘(D) LIMITATION
OF
TOTAL
PROJECT 
COST.—The Secretary shall not include the 
costs to be credited under paragraphs (B) and 
(C) in total project costs in determining the 
amounts of the Federal and non-Federal con-
tributions.’’. 
SEC. 111. The Missouri River Levee System (MRLS) 
Unit L–385 Project, Riverside, Missouri, authorized by 
the Flood Control Act of 1941, Public Law 77–228, and 
the Flood Control Act of 1944, Public Law 78–534, is 
modified to direct the Secretary, acting through the Chief 
of Engineers, to take such action as is necessary to correct 
deficiencies in the L–385 levee system in Riverside, Mis-
souri at full Federal expense at a cost of no more than 
$7,000,000. 
SEC. 112. Section 115 of the Energy and Water De-
velopment and Related Agencies Appropriations Act, 2008 
as contained in division C of Public Law 110–161, is 
amended by striking ‘‘$20,000,000. The Secretary shall 
transfer this facility to the Secretary of the Interior for 
operation and maintenance upon the completion of con-
struction.’’ and inserting in lieu thereof, ‘‘$20,000,000: 
Provided, That the Secretary shall transfer ownership of 
this facility to the Secretary of Health and Human Serv-
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201 
ices for operation and maintenance upon the completion 
of construction.’’. 
SEC. 113. Section 103(c)(7) of the Water Resources 
Development Act of 1992 (106 Stat. 4811–12), as amend-
ed by section 117 of the Energy and Water Development 
Appropriations Act of 2006 (119 Stat. 2255), is further 
amended 
by 
striking 
‘‘15,000,000’’ 
and 
inserting 
‘‘26,000,000’’. 
SEC. 114. Section 3118 of Public Law 110–114 (121 
Stat. 1137) is amended by— 
(1) in paragraph (b) by inserting after ‘‘New 
Mexico’’ the following: ‘‘in accordance with the plans 
recommended in the feasibility report for the Middle 
Rio Grande Bosque, New Mexico, scheduled for com-
pletion in December 2008’’; 
(2) redesignating subsection (d) as subsection 
(e); and 
(3) inserting a new subsection (d): 
‘‘(d) COST SHARING.—Any requirement for non-Fed-
eral participation in a project carried out in the bosque 
of Bernalillo County, New Mexico, pursuant to this section 
shall be limited to the provision of lands, easements, 
rights-of-way, relocations, and dredged material disposal 
areas necessary for construction, operation and mainte-
nance of the project.’’. 
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(b) Section 8468(j) of title 5, United States Code (as 
so redesignated by section 1(b)(1)) is amended— 
(1) in paragraph (1), by striking ‘‘(h)’’ and in-
serting ‘‘(i)’’; and 
(2) in paragraph (2), by striking ‘‘or (h)’’ and 
inserting ‘‘(h), or (i)’’. 
(c) Section 1005(d)(2) of title 39, United States 
Code, is amended— 
(1) by striking ‘‘subsections (i) and (l)(2) of 
section 8344’’ and inserting ‘‘subsections (i), (l), and 
(m)(2) of section 8344’’; and 
(2) by striking ‘‘subsections (f) and (i)(2) of 
section 8368’’ and inserting ‘‘subsections (f), (i), 
and (j)(2) of section 8368’’. 
Æ 
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IV 
House Calendar No. 194 
111TH CONGRESS 
2D SESSION 
H. RES. 1344 
[Report No. 111–479] 
Providing for consideration of the bill (H.R. 5116) to invest in innovation 
through research and development, to improve the competitiveness of 
the United States, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 11, 2010 
Mr. PERLMUTTER, from the Committee on Rules, reported the following reso-
lution; which was referred to the House Calendar and ordered to be print-
ed 
RESOLUTION 
Providing for consideration of the bill (H.R. 5116) to invest 
in innovation through research and development, to im-
prove the competitiveness of the United States, and for 
other purposes. 
Resolved, That at any time after the adoption of this 
resolution the Speaker may, pursuant to clause 2(b) of 
rule XVIII, declare the House resolved into the Committee 
of the Whole House on the state of the Union for consider-
ation of the bill (H.R. 5116) to invest in innovation 
VerDate Mar 15 2010 
22:20 May 11, 2010
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108TH CONGRESS
2D SESSION
H. R. 3782
AN ACT
To amend the State Department Basic Authorities
Act of 1956 to increase the maximum amount of
an award available under the Department of
State rewards program, to expand the eligibility
criteria to receive an award, to authorize non-
monetary awards, to publicize the existence of
the rewards program, and for other purposes.
(1) unconditionally released all political pris-
oners, including Aung San Suu Kyi and other mem-
bers of the National League for Democracy; 
(2) entered into a substantive dialogue with 
democratic forces led by the National League for De-
mocracy and the ethnic minorities of Burma on 
transitioning to democratic government under the 
rule of law; and 
(3) allowed humanitarian access to populations 
affected by armed conflict in all regions of Burma. 
(i) WAIVER.—The President may waive the sanctions 
described in subsections (b) and (c) if the President deter-
mines and certifies to the appropriate congressional com-
mittees that such waiver is in the national interest of the 
United States. 
SEC. 6. AMENDMENTS TO THE BURMESE FREEDOM AND DE-
MOCRACY ACT OF 2003. 
(a) IN GENERAL.—The Burmese Freedom and Democ-
racy Act of 2003 (Public Law 108–61; 50 U.S.C. 1701 note) 
is amended by inserting after section 3 the following new 
section:
manent resident alien, juridical person organized 
under the laws of the United States (including foreign 
branches), or any person in the United States. 
SEC. 4. STATEMENT OF POLICY. 
It is the policy of the United States to— 
(1) condemn the continued repression carried out 
by the SPDC; 
(2) work with the international community, es-
pecially the People’s Republic of China, India, Thai-
land, and ASEAN, to foster support for the legitimate 
democratic aspirations of the people of Burma and to 
coordinate efforts to impose sanctions on those di-
rectly responsible for human rights abuses in Burma; 
(3) provide all appropriate support and assist-
ance to aid a peaceful transition to constitutional de-
mocracy in Burma; 
(4) support international efforts to alleviate the 
suffering of Burmese refugees and address the urgent 
humanitarian needs of the Burmese people; and 
(5) identify individuals responsible for the re-
pression of peaceful political activity in Burma and 
hold them accountable for their actions. 
SEC. 5. SANCTIONS. 
(a) VISA BAN.—
which shall be known as the Table Mountain 
Wilderness. 
(17) The following areas managed by the Royal 
Gorge Field Office and in the Pike National Forest: 
(A) Certain lands which comprise approxi-
mately 38,378 acres, as generally depicted on a 
map entitled ‘‘Beaver Creek Proposed Wilder-
ness Area’’, dated September 17, 2007, which 
shall be known as the Beaver Creek Wilderness. 
(B) Certain lands which comprise approxi-
mately 25,229 acres, as generally depicted on a 
map entitled ‘‘Badger Creek Proposed Wilder-
ness Area’’, dated September 17, 2007, which 
shall be known as the Badger Creek Wilder-
ness. 
(C) Certain lands which comprise approxi-
mately 20,025 acres, as generally depicted on a 
map entitled ‘‘Browns Canyon Proposed Wilder-
ness Area’’, dated September 17, 2007, which 
shall be known as the Browns Canyon Wilder-
ness. 
(18) Certain lands managed by the Royal Gorge 
Resource Area and in the San Isabel National For-
est which comprise approximately 44,372 acres, as 
generally depicted on a map entitled ‘‘Grape Creek 
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‘‘(41) KUSHNEAHIN CREEK.—Approximately 9 
miles of river and lake within VCU 431 of the 
Tongass National Forest, from Barrie Lake to Sum-
ner Strait, to be administered by the Secretary of 
Agriculture as a wild river. 
‘‘(42) KUTLAKU CREEK AND LAKE.—Approxi-
mately 2 miles of river within VCU 403 of the 
Tongass National Forest, from its headwaters to 
Bay of Pillars, to be administered by the Secretary 
of Agriculture as a wild river. 
‘‘(43) LOVELACE CREEK AND TRIBUTARIES.— 
Approximately 9 miles of river within VCU 430 of 
the Tongass National Forest, from its headwaters to 
Keku Straits, to be administered by the Secretary of 
Agriculture as a wild river. 
‘‘(44) MENEFEE CREEK AND LAKE.—Approxi-
mately 2 miles of river within VCU 471.1 of the 
Tongass National Forest, from Menefee Lake to 
Menefee Inlet, to be administered by the Secretary 
of Agriculture as a wild river. 
‘‘(45) OLIVE CREEK.—Approximately 4 miles of 
river within VCU 469 of the Tongass National For-
est, to be administered by the Secretary of Agri-
culture as follows: 
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tisement with the requirements of this Act prior to 
its initial public dissemination. 
‘‘(2) The term ‘advisory review fee’ has the 
meaning indicated for such term in subsection 
(a)(1)(D). 
‘‘(3) The term ‘carry over submission’ means a 
submission for an advisory review for which a fee 
was paid in one fiscal year that is submitted for re-
view in the following fiscal year. 
‘‘(4) The term ‘direct-to-consumer television ad-
vertisement’ means an advertisement for a prescrip-
tion drug product (as defined in section 735(3)) in-
tended to be displayed on any television channel for 
less than 3 minutes. 
‘‘(5) The term ‘DTC advertisement’ has the 
meaning indicated for such term in subsection 
(a)(1)(A). 
‘‘(6) The term ‘operating reserve fee’ has the 
meaning indicated for such term in subsection 
(a)(2)(A). 
‘‘(7) The term ‘person’ includes an individual, 
partnership, corporation, and association, and any 
affiliate thereof or successor in interest. 
‘‘(8) The term ‘process for the advisory review 
of prescription drug advertising’ means the activities
necessary to review and provide advisory comments 
on DTC advertisements prior to public dissemination 
and, to the extent the Secretary has additional staff 
resources available under the program under this 
section that are not necessary for the advisory re-
view of DTC advertisements, the activities necessary 
to review and provide advisory comments on other 
proposed advertisements and promotional material 
prior to public dissemination. 
‘‘(9) The term ‘resources allocated for the proc-
ess for the advisory review of prescription drug ad-
vertising’ means the expenses incurred in connection 
with the process for the advisory review of prescrip-
tion drug advertising for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance,
linguistic and cultural competence of such pro-
grams.’’. 
Æ 
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354 
‘‘(3) the use of the drug or the biological prod-
uct in the food is to enhance the safety of the food 
to which the drug or the biological product is added 
or applied and not to have independent biological or 
therapeutic effects on humans, and the use is in con-
formity with— 
‘‘(A) a regulation issued under section 409 
prescribing conditions of safe use in food; 
‘‘(B) a regulation listing or affirming con-
ditions under which the use of the drug or the 
biological product in food is generally recog-
nized as safe; 
‘‘(C) the conditions of use identified in a 
notification to the Secretary of a claim of ex-
emption from the premarket approval require-
ments for food additives based on the notifier’s 
determination that the use of the drug or the 
biological product in food is generally recog-
nized as safe, provided that the Secretary has 
not questioned the general recognition of safety 
determination in a letter to the notifier; 
‘‘(D) a food contact substance notification 
that is effective under section 409(h); or 
‘‘(E) such drug or biological product had 
been marketed for smoking cessation prior to
(2) OFFSET.—Section 736(g)(4) (21 U.S.C. 
379h(g)(4)) is amended to read as follows: 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the 
fiscal years 2008 through 2010 and the amount of 
fees estimated to be collected under this section for 
fiscal year 2011 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2008 through 2011, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration as provided in paragraph (1), and shall 
be subtracted from the amount of fees that would 
otherwise be authorized to be collected under this 
section pursuant to appropriation Acts for fiscal 
year 2012.’’. 
(f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 
(21 U.S.C. 379h) is further amended by adding at the 
end the following: 
‘‘(k) ORPHAN DRUGS.— 
‘‘(1) EXEMPTION.—A drug designated under 
section 526 for a rare disease or condition and ap-
proved under section 505 or under section 351 of 
the Public Health Service Act shall be exempt from 
product and establishment fees under this section, if 
the drug meets all of the following conditions:
(b) APPROPRIATE ACTION DESCRIBED.—Appropriate 
action under subsection (a)(1) includes— 
(1) suspension of preferential tariff treatment 
under the Agreement with respect to— 
(A) any textile or apparel good exported or 
produced by the person that is the subject of a 
verification under subsection (a)(1) regarding 
compliance described in subsection (a)(2)(A), if 
the Secretary determines that there is insuffi-
cient information to support any claim for pref-
erential tariff treatment that has been made 
with respect to any such good; or 
(B) the textile or apparel good for which a 
claim of preferential tariff treatment has been 
made that is the subject of a verification under 
subsection (a)(1) regarding a claim described in 
subsection (a)(2)(B), if the Secretary deter-
mines that there is insufficient information to 
support that claim; 
(2) denial of preferential tariff treatment under 
the Agreement with respect to— 
(A) any textile or apparel good exported or 
produced by the person that is the subject of a 
verification under subsection (a)(1) regarding 
compliance described in subsection (a)(2)(A), if 
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110 
(1) encouraging innovation and connecting 
qualified individuals with pediatric device ideas with 
potential manufacturers; 
(2) mentoring and managing pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connecting innovators and physicians to ex-
isting Federal and non-Federal resources, including 
resources from the Food and Drug Administration, 
the National Institutes of Health, the Small Busi-
ness Administration, the Department of Energy, the 
Department of Education, the National Science 
Foundation, the Department of Veterans Affairs, 
the Agency for Healthcare Research and Quality, 
and the National Institute of Standards and Tech-
nology; 
(4) assessing the scientific and medical merit of 
proposed pediatric device projects; and 
(5) providing assistance and advice as needed 
on business development, personnel training, proto-
type development, postmarket needs, and other ac-
tivities consistent with the purposes of this section. 
(d) COORDINATION.—
156 
‘‘(D) the number of pediatric formulations 
developed and the number of pediatric formula-
tions not developed and the reasons such for-
mulations were not developed; 
‘‘(E) the labeling changes made as a result 
of studies conducted under such sections; 
‘‘(F) an annual summary of labeling 
changes made as a result of studies conducted 
under such sections for distribution pursuant to 
subsection (k)(2); and 
‘‘(G) information regarding reports sub-
mitted on or after the date of the enactment of 
the Best Pharmaceuticals for Children Act of 
2007. 
‘‘(g) 
LIMITATIONS.—Notwithstanding 
subsection 
(c)(2), a drug to which the six-month period under sub-
section (b) or (c) has already been applied— 
‘‘(1) may receive an additional six-month period 
under subsection (c)(1)(A)(i)(II) for a supplemental 
application if all other requirements under this sec-
tion are satisfied, except that such drug may not re-
ceive any additional such period under subsection 
(c)(1)(B); and 
‘‘(2) may not receive any additional such period 
under subsection (c)(1)(A)(ii).
Proposed Wilderness Area’’, dated September 17, 
2007, which shall be known as the Grape Creek Wil-
derness. 
(19) Certain lands managed by the San Juan 
Field Office and in the San Juan National Forest 
which comprise approximately 32,050 acres, as gen-
erally depicted on a map entitled ‘‘Snaggletooth Pro-
posed Wilderness Area’’, dated September 17, 2007, 
which shall be known as the Snaggletooth Wilder-
ness. 
(20) The following areas managed by the La 
Jara Field Office: 
(A) Certain lands which comprise approxi-
mately 10,863 acres, as generally depicted on a 
map entitled ‘‘Rio Grande Proposed Wilderness 
Area’’, dated September 17, 2007, which shall 
be known as the Rio Grande Wilderness. 
(B) Certain lands which comprise approxi-
mately 23,536 acres, as generally depicted on a 
map entitled ‘‘San Luis Hills Proposed Wilder-
ness Area’’, dated September 17, 2007, which 
shall be known as the San Luis Hills Wilder-
ness. 
(21) The following areas managed by the White 
River Field Office: 
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(A) Certain lands which comprise approxi-
mately 22,439 acres, as generally depicted on a 
map entitled ‘‘Black Mountain-Windy Gulch 
Proposed Wilderness Area’’, dated September 
17, 2007, which shall be known as the Black 
Mountain-Windy Gulch Wilderness. 
(B) Certain lands which comprise approxi-
mately 24,887 acres, as generally depicted on a 
map entitled ‘‘Big Ridge Proposed Wilderness 
Area’’, dated September 17, 2007, which shall 
be known as the Big Ridge Wilderness. 
(C) Certain lands which comprise approxi-
mately 16,781 acres, as generally depicted on a 
map entitled ‘‘Bull Canyon Proposed Wilder-
ness Area’’, dated September 17, 2007, which 
shall be known as the Bull Canyon Wilderness. 
(D) Certain lands which comprise approxi-
mately 25,005 acres, as generally depicted on a 
map entitled ‘‘Oil Spring Mountain Proposed 
Wilderness Area’’, dated September 17, 2007, 
which shall be known as the Oil Spring Moun-
tain Wilderness. 
(E) Certain lands which comprise approxi-
mately 30,735 acres, as generally depicted on a 
map entitled ‘‘Skull Creek Proposed Wilderness 
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to faculty at the grantee institution and at 
other institutions; 
‘‘(iii) an estimate of the number of faculty, 
graduate students (if any), and undergraduate 
students who will be affected by the activities 
carried out by the Center; and 
‘‘(iv) a plan for assessing the effectiveness 
of the Center at accomplishing the goals de-
scribed in subparagraph (A)(ii). 
‘‘(G) In evaluating the applications submitted 
under subparagraph (F), the Director shall consider, 
at a minimum—
‘‘(i) the ability of the applicant to effec-
tively carry out the proposed activities, includ-
ing the dissemination activities described in 
subparagraph (C)(ii)(IV); and 
‘‘(ii) the extent to which the faculty, staff, 
and administrators of the applicant institution 
are committed to improving undergraduate 
science, mathematics, and engineering edu-
cation. 
‘‘(H) In awarding grants under subparagraph 
(A)(ii), the Director shall endeavor to ensure that a 
wide variety of science, technology, engineering, and 
mathematics fields and types of institutions of high-
‘‘(15) KADASHAN
RIVER.—Approximately 8 
miles of river within VCU 235 of the Tongass Na-
tional Forest, from its headwaters to Tenakee Inlet, 
to be administered by the Secretary of Agriculture 
as a wild river. 
‘‘(16) KATZEHIN
RIVER.—Approximately 12 
miles of river within VCU 9 of the Tongass National 
Forest, from the Meade Glacier to Chilkoot Inlet, to 
be administered by the Secretary of Agriculture as 
a wild river. 
‘‘(17) LACE RIVER.—Approximately 20 miles of 
river within VCU 13 of the Tongass National For-
est, from the Meade Glacier to Berners Bay, to be 
administered by the Secretary of Agriculture as a 
wild river. 
‘‘(18) LONG
BAY
RIVER.—Approximately 7 
miles of river within VCU 228 of the Tongass Na-
tional Forest, from its headwaters in the Moore 
Mtns. to Long Bay, to be administered by the Sec-
retary of Agriculture as a wild river. 
‘‘(19) PORT
HOUGHTON
RIVER
AND
SALT 
CHUCK.—Approximately 12 miles of river within 
VCU 78 and 79 of the Tongass National Forest, 
from an unnamed lake at the base of the Coastal 
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‘‘(A) authorizing the acquisition of the con-
tents of the communications as requested, or as 
modified by the judge; 
‘‘(B) requiring the communications service 
provider or custodian, or officer, employee, or 
agent of such service provider or custodian, who 
has authorized access to the information, facili-
ties, or technical assistance necessary to accom-
plish the acquisition to provide such informa-
tion, facilities, or technical assistance necessary 
to accomplish the acquisition and to produce a 
minimum of interference with the services that 
provider, custodian, officer, employee, or agent 
is providing the target of the acquisition; 
‘‘(C) requiring such communications serv-
ice provider, custodian, officer, employee, or 
agent, upon the request of the applicant, to 
maintain under security procedures approved by 
the Attorney General and the Director of Na-
tional Intelligence any records concerning the 
acquisition or the aid furnished; 
‘‘(D) directing the Federal Government 
to— 
‘‘(i) compensate, at the prevailing 
rate, a person for providing information,
‘‘(III) the name and registration 
number of the exporter; 
‘‘(IV) if required under para-
graph (2)(B)(vi)(III), a prominent ad-
visory that the drug is safe and effec-
tive but not bioequivalent to the U.S. 
label drug; 
‘‘(V) if the inactive ingredients of 
the drug are different from the inac-
tive ingredients for the U.S. label 
drug— 
‘‘(aa) a prominent advisory 
that persons with an allergy 
should check the ingredient list 
of the drug because the ingredi-
ents of the drug differ from the 
ingredients of the U.S. label 
drug; and 
‘‘(bb) a list of the ingredi-
ents of the drug as would be re-
quired under section 502(e); and 
‘‘(VI) a copy of any special label-
ing that would be required by the Sec-
retary had the U.S. label drug been 
dispensed by a pharmacist in the 
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