# 67368 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices

the individual named within the **FOR**

**FURTHER INFORMATION CONTACT** 

# section of

this notice.

Dated: September 24, 2012.

Don Wright,

Director, Office of Disease Prevention and

Health Promotion.

[FR Doc. 2012–27425 Filed 11–8–12; 8:45 am]

**BILLING CODE 4150–32–P** 

# DEPARTMENT OF HEALTH AND

**HUMAN SERVICES**

**Centers for Medicare & Medicaid**

**Services**

**[CMS–9075–N]**



# Medicare and Medicaid Programs;

**Quarterly Listing of Program**

**Issuances—July through September**

**2012**

**AGENCY** 

# : Centers for Medicare &

Medicaid Services (CMS), HHS.

**ACTION** 

# : Notice.

**SUMMARY** 

# : This quarterly notice lists

CMS manual instructions, substantive and interpretive regulations, and other

Federal Register notices that were

published from July through September

2012, relating to the Medicare and

Medicaid programs and other programs

administered by CMS.

**FOR FURTHER INFORMATION CONTACT** 

# : It is

possible that an interested party may

need specific information and not be

able to determine from the listed

information whether the issuance or

regulation would fulfill that need.

Consequently, we are providing contact

persons to answer general questions

concerning each of the addenda

published in this notice.

Addenda Contact Phone No.

I CMS Manual Instructions ...................................................................................................... Ismael Torres .......................... (410) 786–1864

II Regulation Documents Published in the **Federal Register** ................................................. Terri Plumb ............................. (410) 786–4481

III CMS Rulings ........................................................................................................................ Tiffany Lafferty ........................ (410) 786–7548

IV Medicare National Coverage Determinations ..................................................................... Wanda Belle ........................... (410) 786–7491

V FDA-Approved Category B IDEs ......................................................................................... John Manlove ......................... (410) 786–6877

VI Collections of Information .................................................................................................... Mitch Bryman .......................... (410) 786–5258

VII Medicare-Approved Carotid Stent Facilities ....................................................................... Sarah J. McClain .................... (410) 786–2294

VIII American College of Cardiology-National Cardiovascular Data Registry Sites ............... JoAnna Baldwin, MS .............. (410) 786–7205

IX Medicare’s Active Coverage-Related Guidance Documents .............................................. Lori Ashby ............................... (410) 786–6322

X One-Time Notices Regarding National Coverage Provisions .............................................. Lori Ashby ............................... (410) 786–6322

XI National Oncologic Positron Emission Tomography Registry Sites ................................... Stuart Caplan, RN, MAS ........ (410) 786–8564

XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ................ JoAnna Baldwin, MS .............. (410) 786–7205

XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ...................................... JoAnna Baldwin, MS .............. (410) 786–7205

XIV Medicare-Approved Bariatric Surgery Facilities ............................................................... Kate Tillman, RN, MAS .......... (410) 786–9252

XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ....................... Stuart Caplan, RN, MAS ........ (410) 786–8564

All Other Information .................................................................................................................. Annette Brewer ....................... (410) 786–6580



# I. Background

Among other things, the Centers for

Medicare & Medicaid Services (CMS) is

responsible for administering the

Medicare and Medicaid programs and

coordination and oversight of private

health insurance. Administration and

oversight of these programs involves the

following: (1) Furnishing information to

Medicare and Medicaid beneficiaries,

health care providers, and the public;

and (2) maintaining effective

communications with CMS regional

offices, State governments, State

Medicaid agencies, State survey

agencies, various providers of health

care, all Medicare contractors that

process claims and pay bills, National

Association of Insurance Commissioners

(NAIC), health insurers, and other

stakeholders. To implement the various

statutes on which the programs are

based, we issue regulations under the

authority granted to the Secretary of the

Department of Health and Human

Services under sections 1102, 1871,

1902, and related provisions of the

Social Security Act (the Act) and Public

Health Service Act. We also issue

various manuals, memoranda, and statements necessary to administer and

oversee the programs efficiently.

Section 1871(c) of the Act requires

that we publish a list of all Medicare

manual instructions, interpretive rules,

statements of policy, and guidelines of

general applicability not issued as

regulations at least every 3 months in

the Federal Register

.

II. Revised Format for the Quarterly

Issuance Notices

While we are publishing the quarterly

notice required by section 1871(c) of the

Act, we will no longer republish

duplicative information that is available

to the public elsewhere. We believe this

approach is in alignment with CMS’

commitment to the general principles of

the President’s Executive Order 13563

released January 2011entitled

‘‘Improving Regulation and Regulatory

Review,’’ which promotes modifying

and streamlining an agency’s regulatory

program to be more effective in

achieving regulatory objectives. Section

6 of Executive Order 13563 requires

agencies to identify regulations that may

be ‘‘outmoded, ineffective, insufficient,

or excessively burdensome, and to

modify, streamline, expand or repeal them in accordance with what has been

learned.’’ This approach is also in

alignment with the President’s Open

Government and Transparency Initiative

that establishes a system of

transparency, public participation, and

collaboration.

Therefore, this quarterly notice

provides only the specific updates that

have occurred in the 3-month period

along with a hyperlink to the full listing

that is available on the CMS Web site or

the appropriate data registries that are

used as our resources. This information

is the most current up-to-date

information and will be available earlier

than we publish our quarterly notice.

We believe the Web site list provides

more timely access for beneficiaries,

providers, and suppliers. We also

believe the Web site offers a more

convenient tool for the public to find

the full list of qualified providers for

these specific services and offers more

flexibility and ‘‘real time’’ accessibility.

In addition, many of the Web sites have

listservs; that is, the public can

subscribe and receive immediate

notification of any updates to the Web

site. These listservs avoid the need to

check the Web site, as notification of


# 67369 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices

updates is automatic and sent to the

subscriber as they occur. If assessing a

Web site proves to be difficult, the

contact person listed can provide

information.

III. How To Use the Notice

This notice is organized into 15

addenda so that a reader may access the

subjects published during the quarter covered by the notice to determine

whether any are of particular interest.

We expect this notice to be used in

concert with previously published

notices. Those unfamiliar with a

description of our Medicare manuals

should view the manuals at http://

www.cms.gov/manuals.

Authority: (Catalog of Federal Domestic

Assistance Program No. 93.773, Medicare— Hospital Insurance, Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program, and Program No. 93.714,

Medical Assistance Program)

Dated: November 5, 2012.

Kathleen Cantwell,

Director, Office of Strategic Operations and

Regulatory Affairs.

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[FR Doc. 2012–27422 Filed 11–08–12; 8:45 am]

**BILLING CODE 4120–01–C**



# DEPARTMENT OF HEALTH AND

**HUMAN SERVICES**

**Food and Drug Administration**

**[Docket No. FDA–2012–D–1057]**



# Draft Guidance for Industry and Food

**and Drug Administration Staff; Highly**

**Multiplexed Microbiological/Medical**

**Countermeasure In Vitro Nucleic Acid**

**Based Diagnostic Devices; Availability**

**AGENCY** 

# : Food and Drug Administration,

HHS.

**ACTION** 

# : Notice.

**SUMMARY** 

# : The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Highly Multiplexed

Microbiological/Medical

Countermeasure In Vitro Nucleic Acid

Based Diagnostic Devices.’’ This draft

guidance is to provide industry and

Agency staff with recommendations for

studies to establish the analytical and

clinical performance of highly

multiplexed microbiological/medical

countermeasures in vitro nucleic acid

based diagnostic devices (HMMDs)

intended to simultaneously detect and

identify multiple pathogen nucleic acids

extracted from a single appropriate

human specimen or culture. This draft

guidance is not final nor is it in effect

at this time.

**DATES** 

# : Although you can comment on

any guidance at any time (see 21 CFR

10.115(g)(5)), to ensure that the Agency

considers your comment on this draft

guidance before it begins work on the

final version of the guidance, submit

either electronic or written comments

on the draft guidance by February 7,

2013.

**ADDRESSES** 

# : Submit written requests for

single copies of the draft guidance

document entitled ‘‘Highly Multiplexed

Microbiological/Medical

Countermeasure In Vitro Nucleic Acid

Based Diagnostic Devices’’ to the

Division of Small Manufacturers,

International, and Consumer Assistance,

Center for Devices and Radiological

Health, Food and Drug Administration,

10903 New Hampshire Ave., Bldg. 66,

rm. 4613, Silver Spring, MD 20993–

0002. Send one self-addressed adhesive

label to assist that office in processing

your request, or fax your request to 301–

847–8149. See the **SUPPLEMENTARY**

**INFORMATION** 

# section for information on

electronic access to the guidance.

Submit electronic comments on the

draft guidance to http:// www.regulations.gov. Submit written

comments to the Division of Dockets

Management (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Identify

comments with the docket number

found in brackets in the heading of this

document.

**FOR FURTHER INFORMATION CONTACT** 

# : John

Hobson, Center for Devices and

Radiological Health, Food and Drug

Administration, 10903 New Hampshire

Ave., Bldg. 66, rm. 5555, Silver Spring,

MD 20993–0002, 301–796–5892.

**SUPPLEMENTARY INFORMATION** 

# :

I. Background

This draft guidance is to provide

industry and Agency staff with

recommendations for studies to

establish the analytical and clinical

performance of HMMDs intended to

simultaneously detect and identify

multiple pathogen nucleic acids

extracted from a single appropriate

human specimen or culture. For the

purposes of this draft guidance

document the multiplex level that is

used to define HMMDs is the capability

to detect ≥ 20 different organisms/

targets, in a single reaction, using a

nucleic acid based technology and

involves testing multiple targets through

a common process of specimen

preparation, amplification and/or

detection, and result interpretation.

HMMDs are used to aid in the diagnosis

of infection.

The scope of this draft guidance

includes nucleic acid based devices that

employ technologies such as

polymerase chain reaction, reversetranscriptase polymerase chain reaction,

bead-based liquid arrays, microarrays,

re-sequencing approaches as well as the

measurement of individual targets

determined by ≥ 20 separate assays that

are reported out simultaneously through

the use of a diagnostic algorithm. This

draft guidance is not intended to

address devices that utilize detection

mechanisms other than nucleic acid

based approaches. The document does

not apply to devices that are intended

to screen donors of blood and blood

components, and donors of human cells,

tissues, and cellular and tissue-based

products for communicable diseases.

II. Significance of Guidance

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115).

The draft guidance, when finalized, will

represent the Agency’s current thinking

on highly multiplexed microbiological/

medical countermeasure in vitro nucleic

acid based diagnostic devices. It does not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy

of the draft guidance may do so by using

the Internet. A search capability for all

CDRH guidance documents is available

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm

. Guidance documents are also available

at http://www.regulations.gov. To

receive ‘‘Highly Multiplexed

Microbiological/Medical

Countermeasure In Vitro Nucleic Acid

Based Diagnostic Devices,’’ you may

either send an email request to

dsmica@fda.hhs.gov to receive an

electronic copy of the document or send

a fax request to 301–847–8149 to receive

a hard copy. Please use the document

number 1803 to identify the guidance

you are requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance refers to currently

approved collections of information

found in FDA regulations. These

collections of information are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in

21 CFR parts 801 and 809 have been

approved under OMB control number

0910–0485; the collections of

information in 21 CFR part 807, subpart

E, have been approved under OMB

control number 0910–0120; and the

collections of information in 21 CFR

part 820 have been approved under

OMB control number 0910–0073.

V. Comments

Interested persons may submit either

written comments regarding this

document to the Division of Dockets

Management (see **ADDRESSES** 

# ) or

electronic comments to http://

www.regulations.gov. It is only

necessary to send one set of comments.

Identify comments with the docket

number found in brackets in the

heading of this document. Received

comments may be seen in the Division

of Dockets Management between 9 a.m.

and 4 p.m., Monday through Friday, and

will be posted to the docket at http://

www.regulations.gov.