27348 Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices 

submitted under § 606.171. CBER 

estimates that 5 percent of the total BPD 

reports submitted to CBER under 

§ 606.171 would need additional 

information submitted in the 

addendum. CBER further estimates that 

it would take between 10 and 20 

minutes to complete the addendum. For 

calculation purposes, CBER is using 15 

minutes. 

Activities such as investigating, 

changing standard operating procedures 

or processes, and follow-up are 

currently required under 21 CFR parts 

211 (approved under OMB control 

number 0910–0139), 606 (approved 

under OMB control number 0910–0116), 

820 (approved under OMB control 

number 0910–0073), and 1271 

(approved under OMB control number 

0910–0543) and, therefore, are not 

included in the burden calculation for 

the separate requirement of submitting a 

deviation report to FDA. 

In the Federal Register of November 

18, 2009 (74 FR 59556), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 

Section 

FDA 

Form No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

600.14 3486 51 7 .78 397 2 .0 794 

606.171 3486 1,533 28 .78 44,120 2 .0 88,240 

1271.350(b) 3486 84 2 .64 222 2 .0 444 

3486A2 77 28 .65 2,206 0 .25 551 .5 

Total 90,029 .5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Five percent of the number of respondents (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206). 

Dated: May 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11541 Filed 5–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Public Health Services Act; Delegation 

of Authority 

Notice is hereby given that I have 

delegated to the Director, Office of 

Public Health Preparedness and 

Response (OPHPR), with authority to 

redelegate, the authority to: 

• Release small quantities of any 

material from the Strategic National 

Stockpile (SNS) to provide intervention 

for specific individual conditions and 

the coordination of transportation assets 

to meet required deadlines. 

• Release small quantities of any 

material from the SNS for testing and 

evaluation or to support governmentrequired programs of vaccinations for 

persons at risk for specific conditions as 

a result of government job requirements. 

• Advance deploy any material from 

the SNS to remain under CDC control 

without release to other government or 

non-government organizations in order 

to prepare for possible response needs 

• Release any material from the SNS 

to comply with requirements as set forth 

by Homeland Security Presidential 

Directive 21 to share stockpiled assets 

with other federal government 

organizations when the material will be 

replaced by the receiving organization. 

This delegation became effective upon 

date of signature. I hereby affirm and 

ratify any actions taken by the Director, 

OPHPR, which involve the exercise of 

these authorities prior to the effective 

date of this delegation. 

Dated: April 26, 2010. 

Thomas Frieden, 

Director, CDC. 

[FR Doc. 2010–11406 Filed 5–13–10; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http:// 

www.workplace.samhsa.gov and http:// 

www.drugfreeworkplace.gov. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh, Division of Workplace 

Programs, SAMHSA/CSAP, Room 2– 

1042, One Choke Cherry Road, 

Rockville, Maryland 20857; 240–276– 

2600 (voice), 240–276–2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Pub. L. 100– 

71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 


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