Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 52051 

16 During the one-year phase-in before the written 

agreement requirement takes effect, the Commission 

will permit sellers to use prerecorded message calls 

made to existing customers to secure their 

agreements to receive prerecorded calls by pressing 

a key on their telephone keypad. Once a script is 

written and recorded, it can be used in all calls 

made by or on behalf of the seller to obtain the 

required agreements. Sellers will be able to include 

the request for the agreement in their regular 

prerecorded calls, thus making the time necessary 

to request the required agreements, and the cost of 

doing so, de minimis during the year-long phasein that will overlap with the final year of the current 

PRA clearance. 

17 This figure includes both the minimal time 

required to create the electronic form and the time 

to encode it in HTML for the seller’s website. 

18 As previously noted, the Commission has 

provided suggested language for this purpose that 

should minimize the time required to modify any 

paper disclosures. 

19 47 CFR 64.1200(b)(2) (requiring disclosure of 

a telephone number ‘‘[d]uring or after the message’’

that consumers who receive a prerecorded message 

call can use to assert a company-specific do-not-call 

request). 

20 This cost is derived from the median hourly 

wage from the 2006 National Occupational 

Employment and Wage Estimates by the Bureau of 

Labor Statistics for management occupations. See 

(http://www.bls.gov/oes/current/oes_nat.htm#b11- 

0000). 

21 This cost is derived from the median hourly 

wage for lawyers from the ‘‘National Compensation 

Survey: Occupational Wages in the United States, 

June 2006,’’ Table 2. See (http://www.stats.bls.gov/ 

ncs/ocs/sp/ncbl0910.pdf). 

22 See, e.g., Comment by IAC/InterActiveCorp & 

HSN LLC (December 18,2006), at 3, available at 

(http://www.ftc.gov/os/comments/tsrrevisedcall

abandon/525547-00600.pdf.) 

This estimate is comprised of the 

following tasks: (1) one-time creation, 

recording, and implementation of a brief 

telephone script requesting a 

consumer’s agreement via a telephone 

keypad response;16 (2) modify or create 

electronic forms or agreements for use 

in emails to consumers or on a 

website;17 (3) one-time revision of any 

existing paper forms (e.g., credit card or 

loyalty club forms, or printed consumer 

contracts) to include a request for the 

consumer’s agreement to receive 

prerecorded calls;18 and (4) legal 

consultation, if needed, regarding 

compliance. 

Any remaining time needed to make 

the required opt-out disclosure for all 

prerecorded calls would pose no greater 

time increment, and arguably less, than 

a similar, pre-existing Federal 

Communications Commission 

disclosure provision that has been in 

effect since 1993.19 In any event, 

because this disclosure applies only to 

prerecorded calls, which are fully 

automated, no additional manpower 

hours would be expended in its 

delivery. 

Other: The revised standard for 

measuring the three percent call 

abandonment rate will not impose any 

new or affect any existing reporting, 

recordkeeping or third-party disclosure 

requirements within the meaning of the 

PRA. The amendment relaxes the 

present requirement that the 

abandonment rate be calculated on a 

‘‘per day per campaign’’ basis by 

permitting, but not requiring, its 

calculation over a 30-day period as 

requested by the industry. Sellers and 

telemarketers already have established 

automated recordkeeping systems to 

document their compliance with the 

current standard. The proposed 

amendment likely will reduce their 

overall compliance burden because it 

relaxes the current requirement. The 

current ‘‘per day’’ requirement has 

forced telemarketers to turn off their 

predictive dialers on many occasions 

when unexpected spikes in call 

abandonment rates occur late in the day, 

and thereby prevented realization of the 

cost savings that predictive dialers 

provide. 

Estimated incremental labor cost 

burden: $3,488,000, rounded 

Recordkeeping: As indicated above, 

staff estimates that existing sellers 

making use of prerecorded calls will 

require 16,753 hours, cumulatively, to 

comply with the amendment’s 

recordkeeping requirements during the 

final year of the current PRA clearance. 

Staff assumes that the aforementioned 

tasks will be performed by managerial 

and/or professional technical personnel, 

at an hourly rate of $38.93.20

Accordingly, incremental labor cost in 

the final year of the current clearance 

would be $652,194. 

Disclosure: Staff estimates that 

approximately 75% of the disclosurerelated tasks previously noted would be 

performed by managerial and/or 

professional technical personnel, again, 

at an hourly rate of $38.93, with 25% 

allocable to legal staff, at an hourly rate 

of $54.35.21

Thus, of the 66,292 total estimated 

disclosure burden hours, 49,719 hours 

would be attributable to managerial 

and/or professional technical personnel, 

with the remaining 16,573 hours 

attributable to legal staff. This yields 

$1,935,561 and $900,743, respectively, 

in labor cost—in total, $2,836,304. 

Cumulatively, for recordkeeping and 

disclosure, labor cost would total 

$3,488,498 for the final year of the 

current clearance. 

Other than the initial recordkeeping 

costs, the amendment’s written 

agreement requirement will impose de 

minimis costs, as discussed above. The 

one possible exception that might arise 

involves credit card or loyalty program 

agreements that retailers revise to 

request agreements from consumers to 

receive prerecorded calls. Retailers 

might have to replace any existing 

supplies of such agreements. Staff 

believes, however, that the one-year 

phase-in of the written agreement 

requirement will allow retailers to 

exhaust existing supplies of any such 

preprinted forms, so that no material 

additional cost would be incurred to 

print revised forms. 

Similarly, staff has no reason to 

believe that the amendment’s 

requirement of an automated interactive 

opt-out mechanism will impose other 

than de minimis costs, for the reasons 

discussed above. The industry 

comments on the amendment uniformly 

support the view that automated 

interactive keypress technologies are 

now affordable, cost-effective, and 

widely available.22 Moreover, most, if 

not all of the industry telemarketers 

who commented, including many small 

business telemarketers, said they are 

currently using interactive keypress 

mechanisms. Thus, it does not appear 

that this requirement will impose any 

material capital or other non-labor costs 

on telemarketers. 

David C. Shonka 

Acting General Counsel 

[FR Doc. E8–20775 Filed 9–8–08; 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Meeting 

ACTION: Meeting Announcement. 

SUMMARY: This notice announces the 

meeting date for the 24th meeting of the 

American Health Information 

Community in accordance with the 

Federal Advisory Committee Act (Pub. 

L. 92–463, 5 U.S.C., App.) The 

American Health Information 

Community will advise the Secretary 

and recommend specific actions to 

achieve a common interoperability 

framework for health information 

technology (IT). 

Meeting Date: September 23, 2008, 

from 8:30 a.m. to 3 p.m. (Eastern). 

ADDRESSES: Hubert H. Humphrey 

building (200 Independence Avenue, 

SW., Washington, DC 20201), The Great 

Hall/Lobby. 

SUPPLEMENTARY INFORMATION: The 

meeting will include a demonstration of 

the Nationwide Health Information 

Network (NHIN); an update on the AHIC 

mstockstill on PROD1PC66 with NOTICES

52052 Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 

Successor organization; a discussion on 

the health information technology 

Strategic Plan; and final reports from the 

Confidentiality, Privacy & Security 

Workgroup and the Population Health/ 

Clinical Care Connections Workgroup. 

FOR FURTHER INFORMATION: Visit http:// 

www.hhs.gov/healthit/ahic.html. 

A Web cast of the Community 

meeting will be available on the NIH 

Web site at: http:// 

www.videocast.nih.gov/. 

If you have special needs for the 

meeting, please contact (202) 690–7151. 

Dated: August 26, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. E8–20675 Filed 9–5–08; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

FDA Clinical Trial Requirements 

Regulations, Compliance, and Good 

Clinical Practice Conference; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Dallas District, in 

cooperation with the Society of Clinical 

Research Associates(SoCRA), is 

announcing a workshop on FDA 

Clinical Trial statutory and regulatory 

requirements. This 2-day workshop for 

the clinical research community targets 

sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting FDA 

regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

is scheduled for Wednesday, November 

19, 2008, from 8 a.m. to 5 p.m. and 

Thursday, November 20, 2008, from 8 

a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Westin Crown Center, 1 

East Pershing Rd., Kansas City, MO 

64118, 816–474–4400, FAX: 816–391–

4438. 

Contact: David Arvelo, Food and Drug 

Administration, 4040 N. Central 

Expressway, suite 900, Dallas, TX 

75204, 214–253–4952, FAX: 214–253–

4970, e-mail: david.arvelo@fda.hhs.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $575 

(member), $650 (nonmember), $525 

(government employee nonmember), or 

$450 (government employee member). 

(Registration fee for nonmembers 

includes a 1-year membership.) The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, 530 West Butler 

Ave., suite 109, Chalfont, PA 18914. To 

register via the Internet go to http:// 

www.socra.org/html/ 

FDA_Conference.htm (FDA has verified 

the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register.) The 

registrar will also accept payment by 

major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–822–

8644, or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Westin Crown Center at the 

reduced conference rate, contact the 

Westin Crown Center (see Location) 

before October 21, 2008. The 

registration fee will be used to offset the 

expenses of hosting the conference, 

including meals, refreshments, meeting 

rooms, and materials. Space is limited; 

therefore interested parties are 

encouraged to register early. Limited 

onsite registration may be available. 

Please arrive early to ensure prompt 

registration. If you need special 

accommodations due to a disability, 

please contact David Arvelo (see 

Contact) at least 21 days in advance of 

the workshop. 

SUPPLEMENTARY INFORMATION: The FDA 

Clinical Trial Requirements Regulations, 

Compliance, and GCP Conference, helps 

fulfill the Department of Health and 

Human Services’ and FDA’s important 

mission to protect the public health by 

educating researchers on proper 

conduct of clinical trials. Topics for 

discussion include the following: (1) 

FDA and confidence in the conduct of 

clinical research; (2) medical device, 

drug, biological product, and food 

additive aspects of clinical research; (3) 

investigator initiated research; (4) Preinvestigational new drug (IND) 

application meetings and FDA meeting 

process; (5) informed consent 

requirements; (6) ethics in subject 

enrollment; (7) FDA regulation of 

Institutional Review Boards; (8) 

electronic records requirements; (9) 

adverse event reporting; (10) how FDA 

conducts bioresearch inspections, and 

(11) what happens after the FDA 

inspection. FDA has made education of 

the research community a high priority 

to assure the quality of clinical data and 

protect research subjects. The workshop 

helps to implement the objectives of 

section 406 of the FDA Modernization 

Act (21 U.S.C. 393) and the FDA Plan 

for Statutory Compliance, which 

includes working more closely with 

stakeholders and ensuring access to 

needed scientific and technical 

expertise. The workshop also furthers 

the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses. 

Dated: September 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20730 Filed 9–5–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; the National Diabetes 

Education Program Comprehensive 

Evaluation Plan 

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 Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

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: The 

National Diabetes Education Program 

Comprehensive Evaluation Plan. Type 

of Information Collection Request: 

Extension of a currently approved 

collection (#0925–0552). Need and Use 

of Information Collection: The National 

Diabetes Education Program (NDEP) is a 

partnership of the National Institutes of 

Health (NIH) and the Centers for Disease 

Control and Prevention (CDC) and more 

than 200 public and private 

organizations. The long-term goals of 

the NDEP are to: Improve the treatment 

and health outcomes of people with 

diabetes, promote early diagnosis, and, 

ultimately, prevent the onset of 

diabetes. The NDEP objectives are: (1) 

mstockstill on PROD1PC66 with NOTICES