datamatters24/research-document-archive huggingface dataset:
‘‘(vii) information submitted in the 
application or any other information avail-
able to the Secretary fails to demonstrate 
that the facility in which the biological 
product 
is 
manufactured, 
processed, 
packed, or held meets standards designed 
to assure that the biological product con-
tinues to be safe, pure, and potent; 
‘‘(viii) the Secretary has withdrawn or 
suspended the license of the reference 
product, for safety or effectiveness reasons, 
or has published a notice of opportunity 
for hearing to withdraw such license for 
safety or effectiveness reasons, or the Sec-
retary has determined that the reference 
product has been withdrawn from sale for 
safety or effectiveness reasons; or 
‘‘(ix) the application contains an un-
true statement of material fact; and 
provides the applicant with a detailed expla-
nation for the decision. 
‘‘(B) DETERMINATIONS ON INTERCHANGE-
ABILITY.—Subject to subparagraph (C) and 
paragraph (10), upon issuing a product license 
for a biological product under subparagraph 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
(A), the Secretary shall make and publish one 
of the following determinations: 
‘‘(i) Such product is interchangeable 
with the reference product for one or more 
specified conditions of use prescribed, rec-
ommended, or suggested in the labeling of 
the biological product. 
‘‘(ii) Interchangeability has not been 
established. 
‘‘(C) DETERMINATION OF INTERCHANGE-
ABILITY
OF
SUBSEQUENT
BIOLOGICAL
PROD-
UCT.—If the Secretary determines that an ap-
plication meets the approval requirements of 
subparagraph (A), and, prior to the issuance of 
a product license, the Secretary has made a de-
termination of interchangeability of another bio-
logical product and the reference product for 
which the exclusivity period under paragraph 
(10) has not expired, the Secretary shall— 
‘‘(i) issue the product license for the 
subsequent biological product; and 
‘‘(ii) defer issuing any determination 
of interchangeability as to the subsequent 
biological product and the reference prod-
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
requiring substantial changes to the methods of 
farming the domestically grown tobacco used by the 
manufacturer, the effective date of that product 
standard shall be not less than 2 years after the 
date of publication of the final regulation estab-
lishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars 
other than little cigars, all pipe tobacco, or all 
roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person, may by a regulation, 
promulgated in accordance with the require-
ments of subsection (c) and paragraph (2), 
amend or revoke a tobacco product standard.
IV 
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 22 
Expressing the sense of Congress that the President should provide notice 
of withdrawal of the United States from the North American Free 
Trade Agreement (NAFTA). 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 10, 2007 
Mr. GOODE (for himself and Mr. JONES of North Carolina) submitted the fol-
lowing concurrent resolution; which was referred to the Committee on 
Ways and Means 
CONCURRENT RESOLUTION 
Expressing the sense of Congress that the President should 
provide notice of withdrawal of the United States from 
the North American Free Trade Agreement (NAFTA). 
Whereas, according to the Department of Commerce, United 
States trade deficits with Canada and Mexico have sig-
nificantly widened since the implementation of the North 
American Free Trade Agreement (NAFTA); 
Whereas, according to the Department of Labor, 1,800,000 
workers have applied for trade adjustment assistance as 
a result of jobs lost because of NAFTA; 
Whereas future unrestricted foreign trucking into the United 
States can pose a safety hazard due to inadequate main-
tenance and inspection, and can act collaterally as a con-
VerDate Aug 31 2005 
05:19 Jan 11, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6300
E:\BILLS\HC22.IH
HC22
ccoleman on PROD1PC71 with BILLS
•HCON 22 IH 
duit for the entry into the United States of illegal drugs 
and terrorist activities; and 
Whereas the economic and physical security of the United 
States is impaired by the potential loss of control of its 
borders attendant to the full operation of NAFTA: Now, 
therefore, be it 
Resolved by the House of Representatives (the Senate 
concurring), That it is the sense of Congress that the 
President should provide written notice of withdrawal of 
the United States from the North American Free Trade 
Agreement (NAFTA) in accordance with Article 2205 of 
the Agreement. 
Æ 
VerDate Aug 31 2005 
05:19 Jan 11, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6301
E:\BILLS\HC22.IH
HC22
ccoleman on PROD1PC71 with BILLS
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 230 
CONCURRENT RESOLUTION 
Whereas every 3 minutes a woman is diagnosed with breast 
cancer; 
Whereas another 180,510 new cases of breast cancer are ex-
pected to be diagnosed in the United States in 2007; 
Whereas breast cancer is the leading cause of death among 
women between the ages of 45 and 54;
•HCON 230 EH 
Whereas 1 out of every 8 women who live to the age of 85 
will develop breast cancer in her lifetime; 
Whereas the survival rate of women who have breast cancer 
is 98.1 percent when detected in the early stages; 
Whereas mammograms and monthly breast self-examinations 
are the key components of early detection; and 
Whereas observing a Breast Cancer Awareness Month would 
provide a special opportunity to offer education on the 
importance of monthly breast self-examinations and an-
nual mammograms: Now, therefore, be it 
Resolved by the House of Representatives (the Senate 
concurring), That Congress— 
(1) supports the observance of Breast Cancer 
Awareness Month in order to provide a special op-
portunity to offer education on the importance of 
monthly breast self-examinations and annual mam-
mograms; 
(2) salutes the more than 2.4 million breast 
cancer survivors in the United States and the efforts 
of victims, volunteers, and professionals who combat 
breast cancer each day; 
(3) recognizes and applauds the national and 
community organizations for their work in pro-
moting awareness about breast cancer, providing in-
formation, and offering treatment to its sufferers; 
and
•HCON 230 EH 
(4) urges organizations and health practitioners 
to use this opportunity to promote awareness about 
breast cancer, to support monthly self-examinations, 
and to encourage annual mammograms. 
Passed the House of Representatives October 29, 
2007. 
Attest: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 230 
CONCURRENT RESOLUTION 
Supporting the observance of Breast Cancer 
Awareness Month, and for other purposes.
IIB 
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 230 
IN THE SENATE OF THE UNITED STATES 
OCTOBER 30, 2007 
Received and referred to the Committee on Health, Education, Labor, and 
Pensions 
CONCURRENT RESOLUTION 
Supporting the observance of Breast Cancer Awareness 
Month, and for other purposes. 
Whereas every 3 minutes a woman is diagnosed with breast 
cancer; 
Whereas another 180,510 new cases of breast cancer are ex-
pected to be diagnosed in the United States in 2007; 
Whereas breast cancer is the leading cause of death among 
women between the ages of 45 and 54; 
VerDate Aug 31 2005 
00:24 Oct 31, 2007
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6300
E:\BILLS\HC230.RFS
HC230
bajohnson on PROD1PC69 with BILLS
HCON 230 RFS 
Whereas 1 out of every 8 women who live to the age of 85 
will develop breast cancer in her lifetime; 
Whereas the survival rate of women who have breast cancer 
is 98.1 percent when detected in the early stages; 
Whereas mammograms and monthly breast self-examinations 
are the key components of early detection; and 
Whereas observing a Breast Cancer Awareness Month would 
provide a special opportunity to offer education on the 
importance of monthly breast self-examinations and an-
nual mammograms: Now, therefore, be it 
Resolved by the House of Representatives (the Senate 
concurring), That Congress— 
(1) supports the observance of Breast Cancer 
Awareness Month in order to provide a special op-
portunity to offer education on the importance of 
monthly breast self-examinations and annual mam-
mograms; 
(2) salutes the more than 2.4 million breast 
cancer survivors in the United States and the efforts 
of victims, volunteers, and professionals who combat 
breast cancer each day; 
(3) recognizes and applauds the national and 
community organizations for their work in pro-
moting awareness about breast cancer, providing in-
formation, and offering treatment to its sufferers; 
and 
VerDate Aug 31 2005 
00:24 Oct 31, 2007
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\HC230.RFS
HC230
bajohnson on PROD1PC69 with BILLS
HCON 230 RFS 
(4) urges organizations and health practitioners 
to use this opportunity to promote awareness about 
breast cancer, to support monthly self-examinations, 
and to encourage annual mammograms. 
Passed the House of Representatives October 29, 
2007. 
Attest: 
LORRAINE C. MILLER, 
Clerk. 
VerDate Aug 31 2005 
00:24 Oct 31, 2007
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\HC230.RFS
HC230
bajohnson on PROD1PC69 with BILLS
validity, or enforceability of any such patent 
that was not identified in the notice. With re-
spect to any such patent identified in the no-
tice, any such action may, notwithstanding 
chapter 87 of title 28, United States Code, be 
brought only in a judicial district identified in 
the notice. 
‘‘(E) DISCRETION
OF
APPLICANTS.—An 
applicant or prospective applicant for a com-
parable biological product under this subsection 
may not be compelled, by court order or other-
wise, to initiate the procedures set forth in this 
paragraph. Nothing in this paragraph requires 
an applicant or a prospective applicant to in-
voke the procedures set forth in this paragraph. 
‘‘(18) PETITIONS AND CIVIL ACTIONS REGARD-
ING APPROVAL OF CERTAIN APPLICATIONS.— 
‘‘(A) IN
GENERAL.—With respect to a 
pending application submitted under paragraph 
(1) or (2), if a petition is submitted to the Sec-
retary that seeks to have the Secretary take, or 
refrain from taking, any form of action relating 
to the approval of the application, including a 
delay in the effective date of the application, 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
the following applies, subject to subparagraph 
(E): 
‘‘(i)(I) The Secretary may not, on the 
basis of the petition, delay approval of the 
application unless the Secretary deter-
mines, within 30 days after receiving the 
petition, that a delay is necessary to pro-
tect the public health. Consideration of a 
petition shall be separate and apart from 
the review and approval of the application. 
‘‘(II) With respect to a determination 
by the Secretary under subclause (I) that 
a delay is necessary to protect the public 
health: 
‘‘(aa) The Secretary shall publish 
on the Internet site of the Food and 
Drug Administration a statement pro-
viding the reasons underlying the de-
termination. 
‘‘(bb) Not later than 10 days 
after making the determination, the 
Secretary shall provide notice to the 
sponsor of the application and an op-
portunity for a meeting with the Com-
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
111TH CONGRESS 
2D SESSION 
H. R. 5827 
AN ACT 
To amend title 11 of the United States Code to include 
firearms in the types of property allowable under the 
alternative provision for exempting property from the 
estate. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
IV 
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 232 
It is the Sense of the Congress that the confidentiality mandates for minors 
should be removed from family planning services programs operating 
under title X of the Public Health Services Act and Medicaid. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 10, 2007 
Mr. MARCHANT submitted the following concurrent resolution; which was 
referred to the Committee on Energy and Commerce 
CONCURRENT RESOLUTION 
It is the Sense of the Congress that the confidentiality man-
dates for minors should be removed from family planning 
services programs operating under title X of the Public 
Health Services Act and Medicaid. 
Whereas title X of the Public Health Service Act, established 
by Congress, was designed to assist in making com-
prehensive voluntary family planning services readily 
available to all persons desiring such service; 
Whereas these services, including the availability of contra-
ception, were extended to minors under the age of 16 as 
a result of the United States Supreme Court decision in 
Carey v. Population Services International; consequently, 
title X clinics can provide minors with free contraceptives 
without a parent’s knowledge or consent; 
VerDate Aug 31 2005 
02:32 Oct 11, 2007
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6300
E:\BILLS\HC232.IH
HC232
bajohnson on PROD1PC69 with BILLS
•HCON 232 IH 
Whereas Medicaid funding for family planning was author-
ized to cover health care services for low-income women 
through a cooperative Federal-State program; 
Whereas in Texas, any provider receiving title X funds from 
the State must also provide services to Medicaid-eligible 
clients and the State cannot require minors to obtain pa-
rental consent before receiving family planning services 
including contraception; 
Whereas these requirements effectively force the State to pro-
vide contraceptives to children under the age of 16 in 
order to finance critical family planning services and re-
duce the likelihood of parental involvement at a time in 
a child’s sexual development when emotional capacity is 
not likely to correspond to physical maturity; and 
Whereas family planning programs operating under title V 
and title XX of the Social Security Act are not prohibited 
from requiring parental consent for the dispensation of 
prescriptions, devaluing the implication that confiden-
tiality is a necessity and sending a mixed message to 
State administrators of family planning programs: Now, 
therefore, be it 
Resolved by the House of Representatives (the Senate 
concurring), That it is the sense of Congress that the con-
fidentiality mandates for minors should be removed from 
family planning services programs operating under title X 
of the Public Health Services Act and Medicaid. 
Æ 
VerDate Aug 31 2005 
02:32 Oct 11, 2007
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6301
E:\BILLS\HC232.IH
HC232
bajohnson on PROD1PC69 with BILLS
(iii) by inserting after subparagraph 
(B) the following: 
‘‘(C) 
a 
notice 
described 
in 
section 
351(k)(17)(B) of the Public Health Service Act, but 
only with respect to a patent identified in such no-
tice,’’; and 
(iv) in the matter following subpara-
graph (C) (as inserted by clause (iii) of 
this subparagraph), by inserting before the 
period the following: ‘‘, or if the notice de-
scribed in subparagraph (C) is provided in 
connection with an application to obtain a 
license to engage in the commercial manu-
facture, use, or sale of a biological product 
claimed in a patent or the use of which is 
claimed in a patent before the expiration of 
such patent’’; and 
(B) by adding at the end the following 
paragraph: 
‘‘(6) (A) This paragraph applies, in lieu of paragraph 
(4), in the case of a patent— 
‘‘(i) which is disclosed in a response to a 
request for patent information pursuant to sub-
paragraph (A) of section 351(k)(17) of the 
Public Health Service Act; 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
‘‘(ii) with respect to which a notice was 
provided pursuant to subparagraph (B) of such 
section; and 
‘‘(iii) for which an action for infringement 
of the patent— 
‘‘(I) was brought after the expiration 
of the 45-day period described in subpara-
graph (C) of such section; or 
‘‘(II) was brought before the expira-
tion of the 45-day period described in sub-
clause (I), but which was dismissed with-
out prejudice or was not prosecuted to 
judgment in good faith. 
‘‘(B) In an action for infringement of a patent 
described in subparagraph (A), the sole and exclu-
sive remedy that may be granted by a court, upon 
a finding that the person who submitted the notice 
described in subparagraph (A)(ii) infringed the pat-
ent, or that any person induced or contributed to in-
fringement of the patent, shall be a reasonable roy-
alty. 
‘‘(C) The owner of a patent that should have 
been disclosed in response to a request for patent in-
formation made by an applicant pursuant to sub-
paragraph (A)(i) of section 351(k)(17) of the Public 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a to-
bacco product standard to be effective on and 
after its publication in the Federal Register and 
until the effective date of any final action taken 
on such amendment if the Secretary determines 
that making it so effective is in the public inter-
est. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN
GENERAL.—The Secretary may 
refer a proposed regulation for the establish-
ment, amendment, or revocation of a tobacco 
product standard to the Tobacco Products Sci-
entific Advisory Committee for a report and 
recommendation with respect to any matter in-
volved in the proposed regulation which requires 
the exercise of scientific judgment. 
‘‘(B) INITIATION OF REFERRAL.—The Sec-
retary may make a referral under this para-
graph— 
‘‘(i) on the Secretary’s own initiative; 
or 
‘‘(ii) upon the request of an interested 
person that—
484 
•HR 3221 EAH2 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of this section, the Secretary may insure, 
upon application by a mortgagee, a home equity con-
version mortgage upon such terms and conditions as 
the Secretary may prescribe, when the home equity 
conversion mortgage will be used to purchase a 1- to 
4-family dwelling unit, one unit of which the mort-
gagor will occupy as a primary residence, and to pro-
vide for any future payments to the mortgagor, based 
on available equity, as authorized under subsection 
(d)(9). 
‘‘(2) LIMITATION ON PRINCIPAL OBLIGATION.—A 
home equity conversion mortgage insured pursuant to 
paragraph (1) shall involve a principal obligation 
that does not exceed the dollar amount limitation de-
termined under section 305(a)(2) of the Federal Home 
Loan Mortgage Corporation Act for a 1-family resi-
dence. 
‘‘(n) REQUIREMENTS ON MORTGAGE ORIGINATORS.— 
‘‘(1) IN
GENERAL.—The mortgagee and any 
other party that participates in the origination of a 
mortgage to be insured under this section shall— 
‘‘(A) not participate in, be associated with, 
or employ any party that participates in or is
I 
111TH CONGRESS 
2D SESSION 
H. R. 5835 
To authorize the use of subpoenas by the Office of Healthy Homes and 
Lead Hazard Control of the Department of Housing and Urban Develop-
ment in investigations of potential violations of the Residential Lead- 
Based Paint Hazard Reduction Act of 1992. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 22, 2010 
Mr. ELLISON (for himself and Mr. BRADY of Pennsylvania) introduced the 
following bill; which was referred to the Committee on Financial Services 
A BILL 
To authorize the use of subpoenas by the Office of Healthy 
Homes and Lead Hazard Control of the Department 
of Housing and Urban Development in investigations 
of potential violations of the Residential Lead-Based 
Paint Hazard Reduction Act of 1992. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Improving Lead-Based 
Paint Investigations Act of 2010’’. 
VerDate Mar 15 2010 
03:29 Jul 24, 2010
Jkt 089200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5835.IH
H5835
jbell on DSKDVH8Z91PROD with BILLS
•HCON 234 EH 
Korea is allowed to subject the people of North Korea to 
persecution and effectively imprison them within its bor-
ders; 
Whereas Special Envoy for Human Rights in North Korea 
Jay Lefkowitz testified before the House Foreign Affairs 
Subcommittee on Asia, the Pacific, and the Global Envi-
ronment on March 1, 2007, that ‘‘the fact that the Gov-
ernment of China is not honoring its international com-
mitments, is not providing genuine access as it is re-
quired to the U.N. High Commissioner on Human 
Rights, I think is really the single most significant issue 
we have outside of the North Korean Government’s own 
emigration policies that is a barrier now to the free move-
ment of people in that region’’; 
Whereas the International Parliamentarians Coalition for 
North Korean Refugees’ Human Rights, a coalition of 
parliamentarians from across the globe, met in Seoul, 
South Korea, on August 29, 2007, and called on the 
international community to increase its efforts to protect 
North Korean refugees; and 
Whereas the Korean-American community, acting through 
various religious and civic organizations, including the 
‘‘Let My People Go Campaign’’, has worked to bring 
awareness to the plight of the hundreds of thousands 
North Korean refugees living in China: Now, therefore, 
be it 
Resolved by the House of Representatives (the Senate 
concurring), That Congress— 
(1) strongly encourages the Government of the 
People’s Republic of China to honor its obligations 
under the United Nations Convention relating to the
•HCON 234 EH 
Status of Refugees, done at Geneva on July 28, 
1951 (189 UNTS 150), as modified by the Protocol 
relating to the Status of Refugees, done at New 
York on January 31, 1967 (606 UNTS 267), by— 
(A) halting the forced repatriation of 
North Koreans who face a well-founded fear of 
persecution if they are returned to North 
Korea; 
(B) making genuine efforts to identify and 
protect the refugees among the North Korean 
migrants encountered by Chinese authorities, 
including providing refugees with a reasonable 
opportunity to request asylum; and 
(C) granting the United Nations High 
Commissioner for Refugees unfettered access to 
such refugees to determine their status and the 
degree of assistance to which they are entitled; 
and
•HCON 234 EH 
(2) recognizes the efforts of the Korean-Amer-
ican community for bringing attention to the plight 
of North Korean refugees. 
Passed the House of Representatives October 29, 
2007. 
Attest: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. CON. RES. 234 
CONCURRENT RESOLUTION 
Calling on the Government of the People’s Republic 
of China to respect the human rights of refugees 
from North Korea.
107TH CONGRESS
1ST SESSION
H. R. 2716
AN ACT
To amend title 38, United States Code, to revise, improve,
and consolidate provisions of law providing benefits and
services for homeless veterans.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,