‘‘SEC. 317K–1. DATA COLLECTION REGARDING SAFE MOTH-
ERHOOD.
‘‘(a) STANDARD DEFINITIONS FOR PREGNANCY-RE-
LATED MORTALITY
AND MORBIDITY.—The Secretary,
acting through the Director of the Centers for Disease
Control and Prevention and in cooperation with State offi-
cials, professional medical experts, medical organizations,
and health care advocacy groups, shall develop a standard
definition of ‘maternal mortality’ and ‘maternal mor-
bidity’.
‘‘(b) GRANTS FOR SURVEILLANCE OF PREGNANCY-
RELATED MORTALITY AND MORBIDITY DATA.—
‘‘(1) IN
GENERAL.—The Secretary, acting
through the Director of the Centers for Disease
Control and Prevention, shall establish a program to
award grants to States, counties, and cities for the
development of surveillance systems, that use the
standard definitions established under subsection
(a), to gather data on maternal mortality and mater-
nal morbidity.
‘‘(2) ELIGIBILITY.—To be eligible to receive a
grant under paragraph (1), a State, county, or city
shall—
‘‘(A) prepare and submit to the Secretary
an application, at such time, in such manner,
and containing such information as the Sec-
retary may require;
‘‘(B) provide an assurance that the appli-
cant will work with the Centers for Disease
Control and Prevention to adopt standard pro-
cedures for the identification, collection, and
analysis of the data that is to be collected under
the grant; and
‘‘(C) provide an assurance that the appli-
cant will contribute $1 (in cash or in kind) to
activities under the grant for every $4 provided
by the Federal Government.
‘‘(3) TECHNICAL
ASSISTANCE.—The Centers
for Disease Control and Prevention shall provide
technical assistance to grantees under this sub-
section.
‘‘(4) INCORPORATION OF DATA INTO REPORT.—
Where determined appropriate by the Secretary,
data collected by the surveillance systems established
under this subsection shall be incorporated into the
report submitted under section 399O(d)(3)(B).
‘‘(c) PREVALENCE OF PRE-TERM LABOR AND DELIV-
ERY.—The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall work
with States and other entities to improve knowledge re-
garding the incidence and prevalence of symptoms and
risk factors for pre-term births.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated, such sums as may be
necessary to carry out this section.’’.
SEC. 122. STUDY ON EFFECTS OF PREGNANCY ON WOMEN.
Section 1004 of the Children’s Health Act of 2000
(42 U.S.C. 285g note) is amended—
(1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and
(2) by inserting after subsection (c), the fol-
lowing:
‘‘(d) STUDY
ON
EFFECTS
OF
PREGNANCY
ON
WOMEN.—As part of the study conducted under this sec-
tion, the Director of the National Institute of Child Health
and Human Development, in collaboration with the Direc-
tor of the Centers for Disease Control and Prevention, the
Commission on Food and Drugs, and other appropriate
Federal officials, shall plan, develop, and implement a pro-
spective cohort study of mothers to determine the effects
of pregnancy on the health of women. Such study shall
evaluate—
‘‘(A) the effects of pregnancy on women’s
health;
‘‘(B) the effects of both preexisting and
chronic conditions, physical impairments, and
mental health problems related to pregnancy;
‘‘(C) the impact of stress and anxiety; and
‘‘(D) environmental health factors that in-
fluence both the mother’s health and that of her
child.’’.
Subtitle D—Public Education and
Outreach
SEC. 131. PURPOSE.
It is the purpose of this subtitle to address the need
for providing women with accurate and up-to-date infor-
mation through a 21st century public education and out-
reach Campaign for Safe Motherhood that shall raise the
public awareness of the issues related to safe motherhood,
including—
(1) preventing pregnancy-related illnesses, in-
jury, and death; and
(2) providing women and other interest parties
with the tools necessary to achieve safe and healthy
pregnancies.
SEC. 132. SAFE MOTHERHOOD CAMPAIGN.
Part P of title III of the Public Health Service Act
(42 U.S.C. 280g et seq.), as amended by section 101, is
further amended by adding at the end the following:
‘‘SEC. 399P. SAFE MOTHERHOOD CAMPAIGN.
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting
through the Director of the Office of Women’s Health and
the Interagency Coordinating Committee on Safe Mother-
hood (referred to in this section as the ‘Coordinating Com-
mittee’) established under section 399O, shall develop and
implement a national public education and health pro-
motion campaign to be known as the Safe Motherhood
Campaign (referred to in this section as the ‘Campaign’).
‘‘(b) ELEMENTS
OF
CAMPAIGN.—The Campaign
shall at a minimum include the following:
‘‘(1) WEBSITE.—An Internet website to be es-
tablished in accordance with subsection (c).
‘‘(2) COMMUNITY PARTNERSHIPS.—The provi-
sion of support for community-based programs to
provide outreach, education, information and health
promotion services and information to give women
the tools they need to achieve a safe and healthy
pregnancy.
‘‘(3) STATE AND LOCAL PARTNERSHIPS.—The
facilitation of consultations with State and local pub-
lic health officials to gain access to the broadest
number of women in an effort to provide outreach
and education assistance and information to help
women succeed in having a safe and healthy preg-
nancy.
‘‘(4) SPECIAL POPULATIONS.—The implementa-
tion of procedures to ensure that activities under the
Campaign are accessible to low-literate, non-English
speaking, and nonnative immigrant communities
where determined appropriate by the Secretary.
‘‘(c) INTERNET WEBSITE.—
‘‘(1) ESTABLISHMENT.—The Secretary, acting
through the Office of Women’s Health and the Co-
ordinating Committee, shall develop and maintain a
single Internet website to provide pregnant women,
and research and health practitioners with the most
up-to-date and accurate information on pregnancy,
in a manner designed to carry out the purpose de-
scribed in paragraph (2).
‘‘(2) PURPOSE.—It is the purpose of the
website established under paragraph (1) to consoli-
date information, research, and data related to preg-
nancy (prenatal, intrapartum, and postpartum) to-
gether in one place and to provide links for women
to other critical websites (Federal agencies, commu-
nity health programs, State and tribal health pro-
grams, and self-help professional and advocacy orga-
nizations).
‘‘(3) ADDRESS.—The Secretary shall ensure
that the uniform resource locator for the website es-
tablished 
under 
paragraph 
(1) 
is
www.pregnancy.gov. If such locator is not available,
the Secretary shall select another similar locator.
‘‘(4) 
CONTENTS.—The 
website 
established
under paragraph (1) shall, at a minimum, contain—
‘‘(A) educational materials for how to suc-
ceed in having the safest pregnancy possible, in-
cluding a description of chronic conditions,
pregnancy-related illnesses, and other health
problems that could pose risks to the mother or
fetus;
‘‘(B) information concerning the safety
and risk of prescription and over-the-counter
medications and other products that women
might use during pregnancy;
‘‘(C) information concerning standards for
clinical care throughout pregnancy;
‘‘(D) information on trends in labor inter-
vention, such as induction, epidural, and cae-
sarean sections, and alternative approaches;
‘‘(E) information concerning the issue of
domestic violence during pregnancy, including
how women can obtain assistance;
‘‘(F) information concerning infertility and
maternal health; and
‘‘(G) information concerning pregnancy-re-
lated workplace laws and policies, such as the
Family and Medical Leave Act of 1993.
‘‘(5) APPROPRIATE FORM OF INFORMATION.—
The information contained on the website estab-
lished under paragraph (1) shall be maintained in a
culturally sensitive and appropriate form.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated, such sums as may be
necessary to carry out this section.’’.
TITLE II—PREGNANT AND
LACTATING WOMEN
SEC. 201. AMENDMENTS TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT.
(a) AMENDMENT TO CHAPTER V.—Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.) is amended by adding at the end the following:
‘‘SEC. 564. SAFE DRUGS AND DEVICES FOR PREGNANT AND
LACTATING WOMEN.
‘‘(a) IMPROVING THE QUALITY OF INFORMATION ON
DRUGS AND BIOLOGICAL PRODUCTS FOR WOMEN WHO
ARE PREGNANT OR LACTATING.—
‘‘(1) MARKETED
DRUGS
FOR
WHICH
ADDI-
TIONAL INFORMATION IS NEEDED.—
‘‘(A) IDENTIFYING
DRUGS
TO
BE
STUD-
IED.—The Secretary, acting through the Direc-
tor of the National Institutes of Health and in
consultation with the Commissioner of Food
and Drugs and experts in maternal and fetal
health, shall—
‘‘(i) identify marketed drugs and bio-
logical products that were not approved or
licensed based on studies in pregnant
women for which studies are needed—
‘‘(I) to establish appropriate dos-
ing for women who are pregnant or
lactating; and
‘‘(II) to investigate the marketed
drugs and biological products’ safe
use for pregnant women and fetuses
through the use of pregnancy reg-
istries and pharmacoepidemiological
databases; and
‘‘(ii) design protocols for the needed
studies described in clause (i).
‘‘(B) STUDYING MARKETED DRUGS.—The
Director of the National Institutes of Health
shall award grants, enter into contracts, or use
other appropriate mechanisms to aid in prompt-
ly completing the studies designed under sub-
paragraph (A), as the National Institutes of
Health’s resources allow.
‘‘(2) POSTMARKETING STUDIES.—As a condi-
tion of approval of an application submitted under
section 505(b)(1) or of a biologics license application
under section 351 of the Public Health Service Act
(42 U.S.C. 262), the Secretary may require that the
holder of the application conduct postmarketing
studies, to be completed and submitted to the Sec-
retary by a date specified by the Secretary, to—
‘‘(A) establish dosing recommendations for
such drug or biological product for women who
are pregnant or lactating; and
‘‘(B) investigate the safe use of such drug
or biological product for pregnant women and
fetuses through the use of pregnancy registries
and pharmacoepidemiological databases.
‘‘(3) 
PREGNANCY
REGISTRIES
AND
PHARMACOEPIDEMIOLOGICAL DATABASES.—
‘‘(A) REGISTRIES.—The Secretary shall
issue guidances on the use and evaluation of
data from pregnancy registries, including data
from centralized registries for drugs and bio-
logical products.
‘‘(B) DATABASES.—
‘‘(i) ESTABLISHMENT.—The Secretary
shall establish or award grants, enter into
contracts and cooperative agreements, and
use other appropriate mechanisms to pro-
vide for pharmacoepidemiological databases
(including a teratogen surveillance system)
to study safety issues related to drugs and
biological products, including safety issues
for pregnant women and fetuses.
‘‘(ii) STUDY AND USE OF DATA.—The
Secretary shall hold workshops and issue
guidances on how to study and use the
data from the pharmacoepidemiological
databases established or provided for under
clause (i).
‘‘(4) CLARIFICATION REGARDING MARKET EX-
CLUSIVITY INTERACTIONS.—A clinical investigation
involved in any study conducted under this sub-
section shall not be considered to be a new clinical
investigation for purposes of clauses (iii) and (iv) of
section 505(j)(5(D).
‘‘(b) IMPROVING COMMUNICATION OF INFORMATION
TO PREGNANT
AND LACTATING WOMEN
AND THEIR
HEALTH CARE PROVIDERS THROUGH DRUG LABEL-
ING.—
‘‘(1) REGULATIONS.—
‘‘(A) PROPOSED REGULATION.—Not later
than 6 months after the date of enactment of
this section, the Secretary shall promulgate a
proposed regulation requiring enhanced commu-
nication of safety and dosage information for
women who are pregnant or lactating in the la-
beling of drugs, including drugs licensed under
section 351 of the Public Health Service Act
(42 U.S.C. 262).
‘‘(B) FINAL
RULE.—Not later than 2
years after the date of enactment of this sec-
tion, the Secretary shall promulgate a final reg-
ulation requiring enhanced communication of
safety and dosage information for women who
are pregnant or lactating in the labeling of
drugs, including drugs licensed under section
351 of the Public Health Service Act (42
U.S.C. 262).
‘‘(2) BIENNIAL REVIEW OF CERTAIN DRUGS.—
Not later than 32 months after the date of enact-
ment of this section, and biennially thereafter, each
person who holds an approved application for a drug
under section 505(b) that was not approved based
on studies of pregnant women or who holds an ap-
proved biologics license application for a drug under
section 351 of the Public Health Service Act (42
U.S.C. 262) that was not licensed based on studies
of pregnant women, shall—
‘‘(A) review any newly available data or in-
formation for such drug, including data or in-
formation from the studies completed under
subsection (a), to determine whether such data
or information, and all other relevant data and
information, warrants a labeling change for
women who are pregnant or lactating; and
‘‘(B) submit to the Secretary—
‘‘(i) a supplement to the holders’ new
drug application or biologics license appli-
cation that includes—
‘‘(I) a summary of the data or
information reviewed under subpara-
graph (A);
‘‘(II) an analysis of why such
data or information warrants a label-
ing change for women who are preg-
nant or lactating;
‘‘(III) a proposal for the labeling
change; and
‘‘(IV) a certification that the re-
view, summary, and analysis is com-
plete and accurate; or
‘‘(ii) a letter that includes—
‘‘(I) a summary of the data or
information, if any, reviewed under
subparagraph (A);
‘‘(II) an analysis of why such
data or information does not warrant
a labeling change for women who are
pregnant or lactating; and
‘‘(III) a certification that the re-
view, summary, and analysis is com-
plete and accurate.
‘‘(3) BIENNIAL SUBMISSIONS.—In the regula-
tions promulgated under paragraph (1), the Sec-
retary shall prescribe requirements for—
‘‘(A) the summary of data or information
reviewed under paragraph (2)(A); and
‘‘(B) the analysis of why such data or in-
formation does or does not warrant a labeling
change required to be submitted to the Sec-
retary in a supplement or in a letter under
paragraph (2)(B).
‘‘(4) PERIODIC REVIEW OF DRUGS.—
‘‘(A) PRIORITY.—Not later than 2 years
after the date of enactment of this section, the
Secretary shall prioritize marketed drugs that
were not approved or licensed based on studies
in pregnant women, considering—
‘‘(i) how widely such drugs are used
by women who are pregnant or lactating;
‘‘(ii) whether new information avail-
able about such drugs may warrant a la-
beling change for such women; and
‘‘(iii) which of such drugs have label-
ing for such women that is most in need
of revision.
‘‘(B) REGULATIONS AND ORDERS.—
‘‘(i) INITIAL REGULATIONS AND OR-
DERS.—Based on the prioritization of
drugs under subparagraph (A), the Sec-
retary shall, as resources allow—
‘‘(I) promulgate regulations for
such drugs that meet the conditions
contained in any applicable mono-
graph to revise safety and dosage in-
formation required in labeling for
women who are pregnant or lactating;
and
‘‘(II) issue orders for other such
drugs to require revised safety and
dosage information required in label-
ing for women who are pregnant or
lactating.
‘‘(ii) SUBSEQUENT REGULATIONS AND
ORDERS.—The Secretary shall periodically
review new data or information as it be-
comes available on the drugs described in
subparagraph (A), and shall promulgate
regulations or issue orders, as appropriate,
to revise safety and dosage information re-
quired in labeling for such drugs for
women who are pregnant or lactating.
‘‘(c) IMPROVING COMMUNICATION AND INFORMATION
ABOUT FETAL RISK FROM DEVICES.—
‘‘(1) RESEARCH ON MATERIALS USED IN DE-
VICES.—
‘‘(A) IDENTIFYING
MATERIALS
TO
BE
STUDIED.—The Secretary, acting through the
Director of the National Institutes of Health
and in consultation with the Commissioner of
Food and Drugs, shall—
‘‘(i) periodically review all available
data and information about the safety for
persons and fetuses of materials used in
devices that may come into contact with,
or be absorbed into, the body;
‘‘(ii) identify materials for which addi-
tional data or information is needed to as-
sess the safety for persons and fetuses of
such materials; and
‘‘(iii) design protocols for studies to
collect data or information described in
clause (ii).
‘‘(B) STUDYING DEVICE MATERIALS.—The
Director of the National Institutes of Health
shall award grants, enter into contracts, or use
other appropriate mechanisms to aid in prompt-
ly completing the studies designed under sub-
paragraph (A), as the National Institutes of
Health’s resources allow.
‘‘(C) SAFETY
STUDIES.—The Secretary
may require a person that manufactures a de-
vice that bears or contains a material for which
the Secretary has designed studies under sub-
paragraph (A), to complete and submit such
studies to the Secretary, by a date specified by
the Secretary.
‘‘(2) REVIEW OF DEVICE MATERIAL AND LA-
BELING.—Considering all available data and infor-
mation about the safety for persons and fetuses of
a material that may come into contact with, or be
absorbed into, the body when used in a device, in-
cluding data and information from studies conducted
under paragraph (1), the Secretary shall—
‘‘(A) require appropriate statements dis-
closing any risks to persons or fetuses from the
material in the labeling of a device that bears
or contains such material; or
‘‘(B) if use of the material in a device pre-
sents an unreasonable and substantial risk of
illness or injury to persons or fetuses, ban the
use of such material in such device.
‘‘(d) LIMITATIONS ON INJUNCTIVE RELIEF TO EN-
SURE PROMPT REVISION OF DRUG AND DEVICE LABEL-
ING.—In an action under section 302 with respect to a
drug or a device deemed to be misbranded under section
502(k) or section 502(l), such misbranding shall not be
the sole basis for any judicial order that requires a person
to cease the manufacturing, distribution, or sale of such
drug or device.
‘‘(e) OUTREACH AND EDUCATION.—The Secretary
shall expand the Women’s Health: Take Time to Care pro-
gram or establish a new program that is directed at—
‘‘(1) women who are pregnant or lactating to
inform such women about the safety issues involved
in taking prescription and over-the-counter drugs,
and using medical devices, while such women are
pregnant or breast feeding; and
‘‘(2) health care providers and the public to
provide information about the safety issues involved
when women, who are pregnant or breast feeding,
take prescription and over-the-counter drugs or use
medical devices.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section,
such sums as are necessary.’’.
(b) AMENDMENT TO ADULTERATED DRUGS AND DE-
VICES.—Section 501(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351(g)) is amended by striking
‘‘device’’ and inserting ‘‘device or it is a device that bears
or contains a material whose use in such a device has been
banned under section 564(c)(2)(B)’’.
(c) AMENDMENT TO MISBRANDED DRUGS AND DE-
VICES.—Section 502 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352) is amended by inserting after
subsection (j) the following:
‘‘(k)(1) If it is a drug; and—
‘‘(2)(A) a study required under section 564(a)(2)
with respect to such drug is not completed and submitted
to the Secretary by the date specified by the Secretary;
‘‘(B) a supplement or letter required to be submitted
to the Secretary under section 564(b)(2)(B) with respect
to such drug is not submitted to the Secretary;
‘‘(C) a supplement or letter required to be submitted
to the Secretary under section 564(b)(2)(B) with respect
to such drug does not include an adequate summary or
analysis of relevant information or data; or
‘‘(D) its labeling does not include safety or dosage
information for pregnant or lactating women required by
the Secretary by regulation or order under section
564(b)(4)(B).
‘‘(l) If it is a device and its labeling does not include
statements required by the Secretary under section
564(c)(2)(A).’’.
(d) AMENDMENT
TO CIVIL PENALTIES.—Section
307(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335b(a)) is amended—
(1) in paragraph (6)(B), by striking ‘‘or’’; and
(2) by inserting after paragraph (7) the fol-
lowing:
‘‘(8) has failed to complete and submit to the
Secretary, by the date specified by the Secretary, a
study required by the Secretary under section
564(a)(2);
‘‘(9) has failed to submit to the Secretary a
supplement or letter required to be submitted to the
Secretary under section 564(b)(2)(B);
‘‘(10) has failed to include an adequate sum-
mary or analysis of relevant information or data in
a supplement or letter required to be submitted to
the Secretary under section 564(b)(2)(B);
‘‘(11) has distributed in interstate commerce a
drug whose labeling does not include safety or dos-
age information for pregnant or lactating women re-
quired by the Secretary by regulation or order under
section 564(b)(4)(B);
‘‘(12) has failed to complete and submit to the
Secretary, by the date specified by the Secretary, a
study required under section 564(c)(1)(C);
‘‘(13) has distributed in interstate commerce a
device whose labeling does not include statements re-
quired by the Secretary under section 564(c)(2)(A);
or
‘‘(14) has distributed in interstate commerce a
device that bears or contains a material whose use
in such device has been banned under section
564(c)(2)(B).’’.
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