Attachment B - 60 day FRN

65737

Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices
propose to provide notified workers
with a Reader Response postcard for
routinely assessing notified study
subjects’ responses to individual letter

notification materials sent to them by
NIOSH. We are requesting approval for
three years. Participation is voluntary
and there is no cost to respondents

except for their time. The total
estimated annualized burden hours are
1,333.

ANNUALIZED BURDEN TABLE
Number of
respondents

Form name
Reader Response Card ...................................................................................

Dated: November 15, 2007.
Marilyn Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22809 Filed 11–21–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[60Day–08–07AA]

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Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

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8,000

Proposed Project
Pilot Project for a National Monitoring
System for Major Adverse Effects of
Medication Use During Pregnancy and
Lactation—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description

Centers for Disease Control and
Prevention

This data collection is based on the
following components of the Public
Health Service Act: (1) Act 42 U.S.C.
241, Section 301, which authorizes
‘‘research, investigations, experiments,
demonstrations, and studies relating to
the causes, diagnosis, treatment, control,
and prevention of physical and mental
diseases and impairments of man.’’ (2)
42 U.S.C. 247b–4, Section 317 C, which
authorizes the activities of the National
Center on Birth Defects and
Developmental Disabilities. This section
was created by Public Law 106–310,
also known as ‘‘the Children’s Health
Act of 2000.’’ This portion of the code
has also been amended by Public Law
108–154, which is also known as the
‘‘Birth Defects and Developmental
Disabilities Prevention Act of 2003’’.
The use of a number of medications
during pregnancy is known to be
associated with serious adverse effects
in children. However, because pregnant
and lactating women are traditionally
excluded from clinical trials, and
because pre-marketing animal studies
do not necessarily predict the
experience of humans, little information
is available about the safety of most
prescription medications during
pregnancy and lactation at the time they
are marketed. Nevertheless, many
women inadvertently use medications
early in gestation before realizing they
are pregnant, and many maternal
conditions require treatment during
pregnancy and breastfeeding to
safeguard the health of both mother and
infant. Currently, the United States does
not have a comprehensive early warning
system for major adverse pregnancy or
infant outcomes related to medication
exposures.

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Number of responses per
respondent
1

Average burden response
(in hours)
10/60

Total burden
(in hours)
1,333

Teratology Information Services (TIS)
utilize trained specialists to provide free
phone consultation, risk assessment,
and counseling about exposures during
pregnancy and breastfeeding—including
medications—to women and healthcare
providers. Altogether, they respond to
approximately 70,000–100,000 inquiries
each year in the United States and
Canada. Because they have direct
contact with pregnant and breastfeeding
women, TIS are in a unique position to
monitor the adverse effects of
medication exposures during pregnancy
and lactation. The objective of this
project is to conduct a pilot study to
assess whether TIS in the United States
can serve as an effective monitoring and
early warning system for major adverse
effects on (1) pregnancy outcomes (e.g.,
live birth, stillbirth, premature birth,
low birth weight, etc.) and (2) maternal
and infant health. The project will
assess the willingness of pregnant and
breastfeeding women who contact a TIS
about medication exposure to
participate in and complete a follow-up
study; whether these women are similar
in demographic characteristics to the
U.S. population of child-bearing age
women; the specificity and
completeness of the information
obtained from such a study about
adverse pregnancy outcomes, and
maternal and infant health; and the
amount of time required to conduct the
follow-up.
Within a continuous six-month
period, three individual TIS will recruit
all women who contact their service (up
to a maximum of 250 enrollees per TIS)
who have used any prescription or overthe-counter medication, vitamin, herbal,
or other dietary supplement during
pregnancy or while breastfeeding to
participate in a follow-up study.
Informed consent to participate will be
obtained from each woman by
telephone. For each pregnant woman
who agrees to participate, the TIS will
then conduct 4 telephone interviews: At
enrollment; during the third trimester of
pregnancy; approximately one month
after delivery; and when the infant is
about 3 months old. For each

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65738

Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices

breastfeeding woman who agrees to
participate, the TIS will then conduct 3
telephone interviews: At enrollment;
approximately one month after
enrollment; and 3 months after
enrollment, if the woman is still taking

medication and still breastfeeding. The
interviews will assess maternal and fetal
health throughout pregnancy, maternal
and infant health at delivery, during the
newborn and early infancy period, and
while breastfeeding, and correlate these

outcomes with medication exposure
during pregnancy and while
breastfeeding. There is no cost to
respondents other than their time.

ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Pregnancy Exposure Group ............................................................................
Lactation Exposure Group ...............................................................................
Pregnancy and Lactation Exposure Group (pregnant women who subsequently breastfeed) ......................................................................................
Total .................................................................................................................

Dated: November 14, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22811 Filed 11–21–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2272-FN]

Medicare and Medicaid Programs;
Approval of the American Osteopathic
Association’s Deeming Authority for
Critical Access Hospitals
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:

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SUMMARY: This notice announces our
decision to approve the American
Osteopathic Association (AOA) for
recognition as a national accreditation
program for critical access hospitals
(CAHs) seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice
is effective December 28, 2007 through
December 28, 2013.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:

I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a CAH provided certain
requirements are met. Sections
1820(c)(2)(B) and 1861(mm) of the
Social Security Act (the Act) establish
distinct criteria for facilities seeking
designation as a CAH. Under this
authority, the minimum requirements

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Total burden
(in hours)

5
4

23/60
20/60

648
99

338
750

5

30/60

845
1,592

A. Verifying Medicare Conditions of
Participation
In general, we approve a CAH for
participation in the Medicare program if
it is participating as a hospital at the
time it applies for CAH designation, and
it is in compliance with parts 482
(Conditions of Participation for
Hospitals) and 485, subpart F
(Conditions of Participation: Critical
Access Hospital (CAHs)).
For a CAH to enter into a provider
agreement, a State survey agency must
certify that the CAH is in compliance
with the conditions or standards set
forth in Section 1820 of the Social
Security Act and part 485 of our
regulations. Thereafter, the CAH is
subject to ongoing review by a State
survey agency to determine whether it
continues to meet the Medicare
requirements. There is, however, an
alternative to State compliance surveys.
Certification by a nationally-recognized
accreditation program can substitute for
ongoing State review.
Section 1865(b)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accreditation organization that
all applicable Medicare conditions are
met or exceeded, we may ‘‘deem’’ those
provider entities as having met the

Frm 00041

Average burden per response
(in hours)

338
74

that a CAH must meet to participate in
Medicare are set forth in regulations at
42 CFR part 485, subpart F (Conditions
of Participation: Critical Access
Hospitals (CAHs)) which determine the
basis and scope of CAH covered
services. Conditions for Medicare
payment for CAHs can be found at 42
CFR 413.70. Applicable regulations
concerning provider agreements are at
42 CFR part 489 (Provider Agreements
and Supplier Approval) and those
pertaining to facility survey and
certification are at part 488, subparts A
and B.

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Number of responses per
respondent

requirements. Accreditation by an
accreditation organization is voluntary
and is not required for Medicare
participation.
If an accreditation organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, a
provider entity accredited by the
national accrediting body’s approved
program may be deemed to meet the
Medicare conditions. A national
accreditation organization applying for
approval of deeming authority under
part 488, subpart A must provide us
with reasonable assurance that the
accreditation organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning re-approval
of accrediting organizations are set forth
at section § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require
accreditation organizations to reapply
for continued approval of deeming
authority every six years, or sooner as
we determine. The American
Osteopathic Association’s (AOA) term
of approval as a recognized
accreditation program for CAHs expires
December 27, 2007.
II. Deeming Applications Approval
Process
Section 1865 (b) (3) (A) of the Act
provides a statutory timetable to ensure
that our review of deeming applications
is conducted in a timely manner. The
Act provides us with 210 calendar days
after the date of receipt of an application
to complete our survey activities and
application review process. Within 60
days of receiving a completed
application, we must publish a notice in
the Federal Register that identifies the
national accreditation body making the
request, describes the request, and
provides no less than a 30-day public

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