57300 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1307–CN] 

RIN 0938–ZA74 

Medicare Program; Criteria and 

Standards for Evaluating Intermediary, 

Carrier, and Durable Medical 

Equipment, Prosthetics, Orthotics, and 

Supplies (DMEPOS) Regional Carrier 

Performance During Fiscal Year 2006; 

Correction Notice 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction notice. 

SUMMARY: This document corrects 

technical errors that appeared in the 

general notice with comment period 

published in the Federal Register on 

September 23, 2005 entitled ‘‘Medicare 

Program; Criteria and Standards for 

Evaluating Intermediary, Carrier, and 

Durable Medical Equipment, 

Prosthetics, Orthotics and Supplies 

(DMEPOS) Regional Carrier 

Performance During Fiscal Year 2006.’’

EFFECTIVE DATE: This correction is 

effective October 1, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Richard Johnson, (410) 786–5633. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 05–18923 of September 23, 

2005 (70 FR 55887), there were 

technical errors that are identified and 

corrected in the Correction of Errors 

section below. 

II. Correction of Errors 

In FR Doc. 05–18923 of September 23, 

2005 (70 FR 55887), make the following 

corrections: 

1. On page 55887, in the third 

column, second paragraph, lines 2 and 

3, the date ‘‘October 24, 2005’’ is 

corrected to read ‘‘October 1, 2005.’’

2. On page 55888, in the first column, 

first paragraph, lines 2 through 4, the 

phrase ‘‘beginning on the first day of the 

first month following publication of this 

notice in the Federal Register’’ is 

corrected to read, ‘‘October 31, 2005’. 

3. On page 55888, in the first column, 

fourth paragraph, lines 5 and 6, the Web 

site address ‘‘or to http:// 

www.regulations.gov’’ is deleted. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: September 26, 2005. 

Jacquelyn Y. White, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 05–19611 Filed 9–29–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0385] 

Draft Guidance for Industry on Using 

Electronic Means to Distribute Certain 

Product Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Guidance for 

Industry: Using Electronic Means to 

Distribute Certain Product Information,’’

dated September 2005. The draft 

guidance explains that persons can 

distribute certain product information, 

such as for recalls and drug safety, by 

electronic means. We encourage the use 

of electronic communications for 

conveying all such important product 

safety information. We are making clear 

in this draft guidance that 

manufacturers may disseminate 

communications by e-mail or other 

electronic methods. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 29, 2005, to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit phone requests to 301–827–

3360. Submit written comments on the 

draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jarilyn Dupont, Office of Policy (HF–

11), Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–3360. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The timely dissemination of 

communications about recalls of FDA 

regulated products, important drug 

safety information, and other important 

product safety information is essential 

for the protection of the public health. 

We have encouraged manufacturers to 

provide such information in a timely 

manner to distributors, doctors, and 

others. Over the years, we have worked 

with manufacturers to promote the use 

of electronic methods of communication 

and encourage the use of innovative 

technologies to disseminate safety 

information, particularly those that 

provide a public health benefit. We are 

making clear in the draft guidance that 

manufacturers may disseminate the 

communications discussed in §§ 7.49 

and 200.5 (21 CFR 7.49 and 200.5) by 

e-mail or other electronic methods. The 

draft guidance also applies to those 

instances, not addressed in any 

regulation, where we recommend that 

manufacturers and distributors 

voluntarily convey certain safety 

information about their products to 

members of the public. 

The use of e-mail and other electronic 

communications has dramatically 

changed how we and the public convey 

information. Electronic communications 

have a number of advantages over 

paper-based communications. They can 

significantly shorten the time between 

an event and the public’s knowledge of 

the event. When the event involves 

product safety, it is even more 

important that accurate safety 

information be transmitted rapidly. Email and other electronic 

communications are generally 

considered more efficient and more 

timely than regular or traditional mail. 

These communications involve 

considerably less cost to the sender than 

older, more traditional delivery services. 

Verification of receipt or delivery is less 

expensive and can be automatically 

accomplished. Any necessary followup 

(such as when receipt of the e-mail is 

not acknowledged) also can be 

accomplished electronically. If receipt is 

never acknowledged, the sender can 

resort to more traditional methods of 

notification. 

We interpret the provisions of §§ 7.49 

and 200.5 to allow the use of e-mail and 

other electronic communication 

methods, such as fax or text messaging, 

to accomplish any recall notification or 

distribution of important safety 

information. Section 7.49(b) provides