Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices 41503 

Licensing Contact: Michael 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases, Research 

Technologies Branch, Electron 

Microscopy Unit, is interested in 

collaborative research to further 

develop, evaluate, or commercialize 

potential applications of this invention, 

including design and development of 

instrumentation for conducting MWFS. 

Please contact Barry U. Buchbinder, 

Ph.D., NIAID/OTD, at 301–594–1696 or 

bbuchbinder@niaid.nih.gov, for more 

information. 

Treatments for Smith-Lemli-Opitz 

Syndrome and Other Disorders of 

Cholesterol Biosynthesis 

Description of Invention: This 

technology provides methods for 

treating Smith-Lemli-Opitz Syndrome 

and other disorders of cholesterol 

biosynthesis. 

Smith-Lemli-Opitz Syndrome (SLOS) 

is an autosomal recessive disorder 

caused by an inborn error of cholesterol 

biosynthesis. It affects an estimated one 

in 20,000 to 60,000 newborns, and is 

most prevalent in Caucasians of Central 

European ancestry. It is characterized by 

distinctive facial features, microcephaly, 

mental retardation or learning 

disabilities, and behavioral problems, as 

well as malformations in many parts of 

the body, such as the heart, lungs, 

kidneys, gastrointestinal tract, and 

genitalia. However, the clinical 

manifestations of this disease can vary 

widely, ranging from relatively 

moderate symptoms to profoundly 

severe and life-threatening symptoms. 

At least 95% of SLOS patients present 

with some degree of mental retardation 

and learning disability. 

Biochemically, SLOS is caused by 

disruption of the DHCR7 gene, which is 

responsible for the final step in the 

production of cholesterol; this results in 

low cholesterol levels and an 

accumulation of toxic byproducts of 

cholesterol biosynthesis in the blood, 

nervous system, and other tissues. 

Supplementary dietary cholesterol is 

provided to SLOS patients, but is often 

of limited clinical benefit; because 

levels of byproducts remain high, they 

may interfere with the uptake of free 

cholesterol. 

Although some of the behavioral and 

learning problems are due to 

developmental problems, a portion of 

these symptoms are likely due to a 

biochemical disturbance. That 

biochemical disturbance is potentially 

treatable. 

In their recent work, the inventors 

have discovered that the accumulation 

in SLOS cells of the cholesterol 

precursor 7–DHC causes abnormal 

sphingolipid storage and transport, 

resulting in a cellular phenotype similar 

to that observed in the lysosomal storage 

disease Niemann-Pick type C (NPC). 

They have also discovered that 

treatment with inhibitors of 

sphingolipid biosynthesis corrects these 

abnormalities, and thus such inhibitors 

are of potential therapeutic benefit for 

the treatment of SLOS, as well as for 

other diseases exhibiting similar defects 

in sphingolipid trafficking. 

This technology claims compounds 

that inhibit sphingolipid biosynthesis 

for use in treating diseases which have 

a secondary Niemann-Pick type C 

disease-like cellular phenotype, 

including SLOS, as well as methods of 

treatment and pharmaceutical 

compositions. 

Applications: Development of 

therapeutics for Smith-Lemli-Opitz 

Syndrome and other diseases which 

have a secondary Niemann-Pick type C 

disease-like cellular phenotype, which 

includes inborn errors of cholesterol 

biosynthesis, Huntington’s disease, 

cystic fibrosis, and autism. 

Development Status: In vitro studies 

have been performed using a 

sphingolipid biosynthesis inhibitor. 

Inventors: Forbes D. Porter et al. 

(NICHD). 

Related Publications: 

1. FD Porter. Malformation syndromes 

due to inborn errors of cholesterol 

synthesis. J Clin Invest. 2002 Sep 15; 

110(6):715–724. [PubMed: 12235098] 

2. XS Jiang et al. Quantitative 

proteomic analysis of inborn errors of 

cholesterol synthesis: Identification of 

altered metabolic pathways in DHCR7 

and SC5D deficiency. Mol Cell 

Proteomics. 2010 Mar 19; Epub ahead of 

print. [PubMed: 20305089] 

3. XS Jiang et al. Activation of Rho 

GTPases in Smith-Lemli-Opitz 

syndrome: pathophysiological and 

clinical implications. Hum Mol Genet. 

2010 Apr 1;19(7):1347–1357. [PubMed: 

20067919] 

4. Tierney et al. Analysis of shortterm behavioral effects of dietary 

cholesterol supplementation in SmithLemli-Opitz syndrome. Am J Med Genet 

A. 2010 Jan;152A(1):91–95. [PubMed: 

20014133] 

Patent Status: 

• U.S. Patent Application No. 12/ 

666,279 filed 19 Jan 2010 (HHS 

Reference No. E–206–2007/0–US–06). 

• Related International patent 

applications. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, Ph.D.; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Section on 

Molecular Dysmorphology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Alan Hubbs, Ph.D. at 301–594– 

4263 or hubbsa@mail.nih.gov for more 

information. 

Dated: July 12, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–17428 Filed 7–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2900–FN2] 

Medicare and Medicaid Programs; 

Approval of the Community Health 

Accreditation Program for Continued 

Deeming Authority for Hospices 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice of Removal of 

Conditional Probationary Status. 

SUMMARY: Based on our review and 

observations, we have determined that 

the standards and processes used by the 

Community Health Accreditation 

Program (CHAP) hospice accreditation 

program meet or exceed our 

requirements. This final notice 

announces our decision to approve 

without condition CHAP’s request for 

continued recognition as a national 

accreditation program for hospices 

seeking to participate in the Medicare or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective November 20, 2009 through 

November 20, 2012. 

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 hospice, provided certain 

requirements are met. Section 

1861(dd)(1) of the Social Security Act 

(the Act) establishes distinct criteria for 

entities seeking designation as a hospice 


srobinson on DSKHWCL6B1PROD with NOTICES
41504 Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices 

program. Under this authority, the 

regulations at 42 CFR part 418 specify 

the conditions that a hospice must meet 

in order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for hospice care. Provider 

agreement regulations are located in 42 

CFR part 489 and regulations pertaining 

to the survey and certification of 

facilities are located in 42 CFR part 488. 

Generally, in order to enter into an 

agreement, a hospice facility must first 

be certified by a State survey agency as 

complying with conditions or 

requirements set forth in part 418 of our 

regulations. Then, the hospice is subject 

to regular surveys by a State survey 

agency to determine whether it 

continues to meet these requirements. 

There is an alternative, however, to 

surveys by State agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization (AO) 

that all applicable Medicare conditions 

or requirements are met or exceeded, we 

may deem those provider entities as 

having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. 

A national AO applying for approval 

of deeming authority under part 488, 

subpart A, must provide us with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning re-approval 

of AOs are set forth at § 488.4 and 

§ 488.8(d)(3). The regulations at 

§ 488.8(d)(3) require AOs to reapply for 

continued approval of deeming 

authority every 6 years, or sooner as 

determined by CMS. The regulation at 

§ 488.8(f)(3)(i) provides CMS the 

authority to grant conditional approval 

of an AO’s deeming authority, with a 

probationary period of up to 180 days, 

if the AO has not adopted comparable 

standards during the reapplication 

process. 

We received a complete application 

from CHAP for continued recognition as 

a national AO for hospices on March 27, 

2009. In accordance with the 

requirements at § 488.4 and 

§ 488.8(d)(3), we published a proposed 

notice on May 22, 2009 (74 FR 24015) 

and a final notice announcing our 

decision to conditionally approve 

CHAP’s hospice program subject to 

probationary conditions on October 23, 

2009 (74 FR 54832). This final notice 

provides CMS’ final determination in 

response to the conditional approval 

with a 180-day probationary period 

granted to CHAP on October 23, 2009. 

This notice is required to be published 

no later than July 18, 2010. 

II. Deeming Applications Approval 

Process 

Section 1865(a)(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 

comment period. At the end of the 210- 

day period, we must publish a notice in 

the Federal Register of our approval or 

denial of the application. In accordance 

with § 488.8(f)(2), if CMS determines 

following the deeming authority review 

that the organization has failed to adopt 

requirements comparable to CMS 

requirements, the AO may be given a 

conditional approval of its deeming 

authority for a probationary period of up 

to 180 days to adopt comparable 

requirements. Within 60 days after the 

end of this period, we must make a final 

determination as to whether or not the 

CHAP accreditation program for 

hospices is comparable to CMS 

requirements and issue an appropriate 

notice that includes our reasons for our 

determination. 

III. Provisions of the October 23, 2009 

Final Notice 

Our review of CHAP’s renewal 

application for hospice deeming 

authority revealed that CHAP had ongoing, serious, widespread areas of noncompliance. Specifically, CHAP’s 

inability to provide us with accurate, 

timely data on deemed providers; lack 

of complete and accurate deemed 

facility survey files; and, failure to 

ensure that recertification surveys are 

conducted on an interval not exceeding 

36 months. Due to the significant 

number of areas of noncompliance 

identified during the review of CHAP’s 

deeming authority, we conditionally 

approved CHAP’s hospice accreditation 

program with a 180 day probationary 

period. Under 1865(a)(2) of the Act and 

our regulations at § 488.4 and § 488.8, 

we conducted a comparability review of 

CHAP’s hospice accreditation program 

to determine compliance with Medicare 

requirements for hospices at 42 CFR 

part 418. 

IV. Provisions of the Final Notice 

A. Differences Between CHAP’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

During the 180 day probationary 

period, we conducted a comparison of 

CHAP’s accreditation requirements for 

hospices to our current Medicare 

conditions of Participation (CoPs) as 

outlined in the State Operations Manual 

(SOM). We also conducted a corporate 

onsite visit to validate proper 

application of the requirements. Our 

review and evaluation of CHAP’s 

deeming application yielded the 

following: 

• CHAP’s survey files were complete, 

accurate, and consistent with the 

requirements at § 488.6(a). 

• CHAP’s recertification surveys for 

hospices are conducted no later than 36 

months after the date of the previous 

standard survey in accordance with the 

requirements at § 488.20(a). 

• CHAP’s data submission are 

accurate, complete and timely in 

accordance with the requirements at 

§ 488.4(b). 

• CHAP met the requirements at 

section 2728 of the SOM by developing 

an electronic plan of correction that 

specifically addressed the ‘‘who, what, 

when, and how’’ the hospice would 

correct each deficiency cited and ensure 

ongoing compliance. 

• CHAP met requirements at 

§ 488.28(a) and section 2728 of the SOM 

as evidenced by review of the survey 

files. 

• CHAP policy regarding 

establishment of an effective date for 

new providers is consistent with the 

requirements at § 488.13. 

B. Term of Approval 

Based on the review and observations, 

we have determined that CHAP’s 

hospice accreditation program meets or 

exceeds our requirements. Therefore, we 

approve CHAP as a national AO for 

hospices that request participation in 

the Medicare program, effective 

November 20, 2009 through November 

20, 2012. Under § 488.8(f)(4), notice was 

given to CHAP on October 23, 2009 (74 

FR 54832). 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices 41505 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: June 29, 2010. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

[FR Doc. 2010–17405 Filed 7–15–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Environmental Health 

Sciences Review Committee. 

Date: August 10–12, 2010. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T. W. Alexander Drive, Conference 

Rooms A, B, and C, Research Triangle Park, 

NC 27709. 

Contact Person: Linda K Bass, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat’l Institute of 

Environmental Health Sciences, P.O. Box 

12233, MD EC–30, Research Triangle Park, 

NC 27709, (919) 541–1307. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: July 12, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–17432 Filed 7–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR) 

ATSDR–263; Notice of National 

Conversation on Public Health and 

Chemical Exposures Leadership 

Council Meeting 

Time and Date: 1 p.m.–5 p.m. EDT, 

Tuesday, July 27, 2010. 

Location: Teleconference. 

Status: The public is invited to listen 

to the meeting by phone; see ‘‘contact for 

additional information’’ below. 

Purpose: This is the fifth meeting of 

the National Conversation on Public 

Health and Chemical Exposures 

Leadership Council, which is convened 

by RESOLVE, a non-profit independent 

consensus-building organization. The 

National Conversation on Public Health 

and Chemical Exposures is a 

collaborative initiative supported by 

NCEH/ATSDR through which many 

organizations and individuals are 

helping develop an action agenda for 

strengthening the nation’s approach to 

protecting the public’s health from 

harmful chemical exposures. The 

Leadership Council provides overall 

guidance to the National Conversation 

project and is responsible for issuing the 

final action agenda. For additional 

information on the National 

Conversation on Public Health and 

Chemical Exposures, visit this Web site: 

http://www.atsdr.cdc.gov/ 

nationalconversation/. 

Meeting Agenda: The meeting will 

include discussing (1) options for 

developing a results-oriented action 

agenda, (2) progress on work group 

reports, (3) updates on the community 

conversation process, and (4) 

Leadership Council operations. 

Contact for Additional Information: If 

you would like to receive additional 

information on listening to the meeting 

by phone, please contact: 

nationalconversation@cdc.gov or Ben 

Gerhardstein at 770–488–3646. 

Dated: July 9, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–17357 Filed 7–15–10; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: AIDS/HIV Small Business 

Innovative Research Applications. 

Date: July 29, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Mark P. Rubert, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Nutrition and Diabetes. 

Date: August 2–3, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Reed A. Graves, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6166, 

MSC 7892, Bethesda, MD 20892, (301) 402– 

6297, gravesr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 


srobinson on DSKHWCL6B1PROD with NOTICES