30576 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

LPN, etc.) who completes questions 

pertaining to the beneficiary’s medical 

condition and signs the CMN. The 

physician or other clinician returns the 

CMN to the supplier who has the option 

to maintain a copy and then submits the 

CMN (paper or electronic) to CMS, 

along with a claim for reimbursement. 

Due to a technical oversight on the 

part of CMS, an important question on 

CMN Form 10269 was omitted from the 

last OMB submission that would allow 

claims with an apnea-hypopnea index 

(AHI) or respiratory disturbance index 

(RDI) greater than or equal to 5 without 

symptoms for Criterion 2 be paid for by 

the Medicare program. The omission of 

the following question ‘‘Does the patient 

have documented evidence of at least 

one of the following: Excessive daytime 

sleepiness, impaired cognition, mood 

disorders, insomnia, hypertension, 

ischemic heart disease or history of 

stroke’’ could cause improper payment 

of claims without regards as to whether 

the patient has signs or symptoms in 

support of meeting the applicable 

coverage criteria for PAP devices. We 

are resubmitting this information 

collection request to have the revised 

CMN Form 10269 approved. None of the 

other CMN forms have changed. 

Form Number: CMS–846–849, 854, 

10125, 10126, 10269 (OMB# 0938– 

0679); Frequency: Occasionally; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 59,200; Total 

Annual Responses: 6,480,000; Total 

Annual Hours: 1,296,000. (For policy 

questions regarding this collection 

contact Doris Jackson at (410) 786–4459. 

For all other issues call (410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by August 25, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: June 18, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–15193 Filed 6–25–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–R–205 and CMS– 

R–206] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements Referenced in 

HIPAA title I for the Individual Market, 

Supporting Regulations at 45 CFR 148 

(148.120, 148.122, 148.124, 148.126, 

and 148.128), Forms and Instructions; 

Use: The provisions of title I of the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

amend the Public Health Service Act 

(PHS Act) and are designed to make it 

easier for people to get access to health 

care coverage; to reduce the limitations 

that can be put on the coverage; and to 

make it more difficult for issuers to 

terminate the coverage. The information 

collection requirements will ensure that 

issuers in the individual market comply 

with HIPAA title I, provide individuals 

with certificates of creditable coverage 

necessary to demonstrate prior 

creditable coverage and file 

documentation with CMS for review in 

a Federal direct enforcement state. 

Requirements must also ensure states’ 

flexibility to implement state alternative 

mechanisms. Form Number: CMS–R– 

205 (OMB#: 0938–0703); Frequency: 

Reporting—Yearly and Occasionally; 

Affected Public: Business or other Forprofit and Not-for-profit institutions; 

Number of Respondents: 2,042; Total 

Annual Responses: 2,979,801; Total 

Annual Hours: 856,384. (For policy 

questions regarding this collection 

contact Louis Blank at 410–786–5511. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements in HIPAA title 

I for the Group Market, Supporting 

Regulations 45 CFR 146 (146.111, 

146.115, 146.117, 146.150, 146.152, 

146.160 and 146.180) Forms and 

Instructions; Use: The provisions of title 

I of the Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) are 

designed to make it easier for people to 

get access to health care coverage and to 

reduce the limitations that can be put on 

the coverage. This collection pertains to 

notices issued by group health 

insurance issuers and self-funded nonFederal governmental plans as required 

by 45 CFR 146. These notices are 

triggered by the issuance of certificates 

of creditable coverage; notification of 

preexisting condition exclusions; 

notification of special enrollment rights; 

and State review of issuers’ filings of 

group market products or similar 

Federal review in cases in which a State 

is not enforcing a HIPAA group market 

provision. Form Number: CMS–R–206 

(OMB#: 0938–0702); Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector; Business or other Forprofit and Not-for-profit institutions, 

and State, Local, or Tribal Governments; 

Number of Respondents: 8,050; Total 

Annual Responses: 37,002,217; Total 

Annual Hours: 2,920,012. (For policy 

questions regarding this collection 

contact Louis Blank at 410–786–5511. 

For all other issues call 410–786–1326.) 

To be assured consideration, 

comments and recommendations for the 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30577 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on July 27, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: June 18, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–15189 Filed 6–25–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NCCAM Customer Service 

Data Collection 

Summary: 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 

National Center for Complementary and 

Alternative Medicine (NCCAM), at the 

National Institutes of Health (NIH), will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: NCCAM 

Customer Service Data Collection. Type 

of Information Collection Request: 

Revision. Need and Use of Information 

Collection: NCCAM provides the public, 

patients, families, health care providers, 

complementary and alternative 

medicine (CAM) practitioners, and 

others with the latest scientifically 

based information on CAM and 

information about NCCAM’s programs 

through a variety of channels, including 

its toll-free telephone information 

service and its quarterly newsletter. To 

ensure that NCCAM is effectively 

serving all audiences, NCCAM needs to 

continue to measure customer 

satisfaction with NCCAM telephone 

interactions. This effort involves a 

telephone survey consisting of 10 

questions, which are asked of 25 percent 

of all callers, for an annual total of 

approximately 1,210 respondents. 

NCCAM uses the data collected from the 

surveys to characterize NCCAM users 

and help program staff measure user 

satisfaction, assess impact of their 

communication efforts, tailor services to 

the public and health care providers, 

measure service use among special 

populations, and assess the most 

effective media and messages to reach 

these audiences. Frequency of Response: 

Once. Affected Public: Individuals and 

households. Type of Respondents: 

Patients, spouses/family/friends of 

patients, health care providers, 

physicians, CAM practitioners, or other 

individuals contacting the NCCAM 

Clearinghouse. 

The annual reporting burden is as 

follows. 

Type of respondents 

Estimated number of respondents 

Estimated number of responses per respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

Telephone survey: 

Individuals or households ................................................................. 1,210 1 0.075 91 

The annualized cost to respondents is 

estimated at $1,770 for the telephone 

survey. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on the following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions; (3) Ways 

to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

For Further Information Contact: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, NCCAM, 31 Center 

Drive, Room 2B11, Bethesda, MD 

20892–2182; or fax your request to 301– 

402–4741; or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: June 18, 2009. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–15058 Filed 6–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0264] 

Amended Authorization of Emergency 

Use of Doxycycline Hyclate Tablet 

Emergency Kits for Eligible United 

States Postal Service Participants in 

the Cities Readiness Initiative and 

Their Household Members; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the Emergency Use 

Authorization (EUA) (the Authorization) 

for doxycycline hyclate tablet 

emergency kits for eligible U.S. Postal 

Service (USPS) participants in the Cities 

Readiness Initiative (CRI) and their 

household members issued on October 

3, 2008, under the Federal Food, Drug, 

and Cosmetic Act (the act), as requested 

by the Biomedical Advanced Research 

and Development Authority (BARDA), 

Office of the Assistant Secretary for 

Preparedness and Response (ASPR),