Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 29489 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OTPS

Form name 

Number of 

facilities 

(OTPs) 

Responses 

per facility 

Burden/ 

response 

(hours) to OTP 

Annual burden 

(hours) to 

OTPs 

SAMHSA OTP Mortality Form ......................................................................... 1,200 2 per year 0.5 1200.00 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR MEDICAL EXAMINER (ME) 

Form name Number of ME 

follow-ups 

Responses 

per ME 

Burden/ 

response 

(hours) for ME 

Annual 

burden 

(hours) for ME 

SAMHSA OTP mortality form .......................................................................... 230 1 per year 0.1 2.3 

SAMHSA believes that the 

recordkeeping requirements in the 

regulation are customary and usual 

practices within the medical and 

rehabilitative communities and has not 

calculated a response burden for them. 

The recordkeeping requirements set 

forth in 42 CFR 8.4, 8.11 and 8.12 

include maintenance of the following: 5- 

year retention by accreditation bodies of 

certain records pertaining to 

accreditation; documentation by an OTP 

of the following: a patient’s medical 

examination when admitted to 

treatment, A patient’s history, a 

treatment plan, any prenatal support 

provided the patient, justification of 

unusually large initial doses, changes in 

a patient’s dosage schedule, justification 

of unusually large daily doses, the 

rationale for decreasing a patient’s clinic 

attendance, and documentation of 

physiologic dependence. 

The rule also includes requirements 

that OTPs and accreditation 

organizations disclose information. For 

example, 42 CFR 8.12(e)(1) requires that 

a physician explain the facts concerning 

the use of opioid drug treatment to each 

patient. This type of disclosure is 

considered to be consistent with the 

common medical practice and is not 

considered an additional burden. 

Further, the rule requires, under Sec. 

8.4(i)(1) that accreditation organizations 

shall make public their fee structure; 

this type of disclosure is standard 

business practice and is not considered 

a burden. 

The information requested from OTPs 

on mortality report form should be 

readily available to any OTP that has 

met accreditation standards. The OTP 

should not find any need to otherwise 

analyze or synthesize new data in order 

to complete this form. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: June 15, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–14554 Filed 6–19–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–0278] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

To request a copy of these requests, call 

the CDC Reports Clearance Officer at 

(404) 639–5960 or send an e-mail to 

omb@cdc.gov. Send written comments 

to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Hospital Ambulatory 

Medical Care Survey [OMB No. 0920– 

0278]—Revision—National Center for 

Health Statistics (NCHS), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall collect 

statistics on ‘‘utilization of health care’’ 

in the United States. The National 

Hospital Ambulatory Medical Care 

Survey (NHAMCS) has been conducted 

annually since 1992. This revision seeks 

approval to collect data for an 

additional three years and to expand the 

survey to include free-standing 

ambulatory surgical centers. The 

purpose of NHAMCS is to meet the 

needs and demands for statistical 

information about the provision of 

ambulatory medical care services in the 

United States. Ambulatory services are 

rendered in a wide variety of settings, 

including physicians’ offices and 

hospital outpatient and emergency 

departments. 

The target universe of NHAMCS is inperson visits made to emergency 

departments (EDs) and outpatient 

departments (OPDs) of non-Federal, 

short-stay hospitals (hospitals with an 

average length of stay of fewer than 30 

days) or those whose specialty is general 

(medical or surgical) or children’s 

general. In 2009, NHAMCS was 

expanded to include visits to hospitalbased ambulatory surgery centers 

(ASCs). NCHS seeks OMB approval to 

expand NHAMCS to include freestanding ASCs in 2010. The objective of 

this new collection will be to collect 

data about free-standing ambulatory 

surgery centers, the patients they serve, 

and the services they deliver. The intent 

is for NHAMCS to become the principal 

source of data on ASC services in the 

United States. The data to be collected 

include patient characteristics, 

diagnoses, surgical and nonsurgical 

procedures, provider and type of 

anesthesia, time in and out of surgery 

and postoperative care, and discharge 

disposition. 

Users of NHAMCS data include, but 

are not limited to, congressional offices, 

Federal agencies, State and local 

governments, schools of public health, 

colleges and universities, private 

industry, nonprofit foundations, 

professional associations, clinicians, 

researchers, administrators, and health 

planners. There are no costs to the 

respondents other than their time. The 


pwalker on PROD1PC71 with NOTICES
29490 Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices 

1For prescription drugs and biologics, section 

502 of the act requires advertisements to contain 

‘‘information in brief summary relating to side 

effects, contraindications, and effectiveness’’ (21 

U.S.C. 352(n)). 

2See Swartz, L., S. Woloshin, W. Black, et al., The 

Role of Numeracy in Understanding the Benefit of 

total estimated annualized burden hours 

are 10,832. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Hospital Chief Executive Officer ..................... Hospital Induction (NHAMCS–101) ................ 482 1 1 

Ancillary Service Executive ............................ Freestanding ASC Induction (NHAMCS– 

101FS).

200 1 1.5 

Ancillary Service Executive ............................ Ambulatory Unit Induction (NHAMCS–101U) 1,779 1 1 

Physician/Registered Nurse/Medical Record 

Clerk.

ED Patient Record form NHAMCS–100 (ED) 225 100 7/60 

Physician/Registered Nurse/Medical Record 

Clerk.

OPD Patient Record form NHAMCS–100 

(OPD).

128 200 6/60 

Physician/Registered Nurse/Medical Record 

Clerk.

ASC Patient Record Form NHAMCS–100 

(ASC).

208 100 6/60 

Medical Record Clerk ..................................... Pulling and re-filing Patient Records (ED, 

OPD, and ASC).

425 133 1/60 

Physician/Physician Assistant/Nurse Practitioner/Nurse Midwife.Cervical Cancer Screening Supplement 

(CCSS) (NHAMCS–906).

255 1 15/60 

Dated: June 15, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–14553 Filed 6–19–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0263] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Presentation of Quantitative 

Effectiveness Information to 

Consumers in Direct-to-Consumer 

Television and Print Advertisements 

for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the Experimental Study of Presentation 

of Quantitative Effectiveness 

Information to Consumers in Direct-toConsumer (DTC) Television and Print 

Advertisements for Prescription Drugs. 

This study is designed to communicate 

quantitative information about product 

benefits in DTC print and television ads. 

DATES: Submit written or electronic 

comments on the collection of 

information by [August 21, 2009 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Liz 

Berbakos, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3792. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Study of Presentation of 

Quantitative Effectiveness Information 

to Consumers in Direct-to-Consumer 

(DTC) Television and Print 

Advertisements for Prescription 

Drugs—New 

The Federal Food, Drug, and Cosmetic 

Act (the act) requires that 

manufacturers, packers, and distributors 

(sponsors) who advertise prescription 

human and animal drugs, including 

biological products for humans, disclose 

in advertisements certain information 

about the advertised product’s uses and 

risks.1 By its nature, the presentation of 


pwalker on PROD1PC71 with NOTICES