Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices 27347 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–11568 Filed 5–13–10; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0545] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Biological 

Products: Reporting of Biological 

Product Deviations and Human Cells, 

Tissues, and Cellular and TissueBased Product Deviations in 

Manufacturing; Form FDA 3486 and 

Addendum 3486A 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 14, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0458. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Biological Products: Reporting of 

Biological Product Deviations and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Product Deviations in 

Manufacturing; Form FDA 3486 and 

Addendum 3486A—(OMB Control 

Number 0910–0458)—Extension 

Under section 351 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262), all biological products, including 

human blood and blood components, 

offered for sale in interstate commerce 

must be licensed and meet standards, 

including those prescribed in the FDA 

regulations, designed to ensure the 

continued safety, purity, and potency of 

such products. In addition under 

section 361 of the PHS Act (42 U.S.C. 

264), FDA may issue and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between the 

States or possessions or from foreign 

countries into the States or possessions. 

Further, the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 351) 

provides that drugs and devices 

(including human blood and blood 

components) are adulterated if they do 

not conform with current good 

manufacturing practice (CGMP) assuring 

that they meet the requirements of the 

act. Establishments manufacturing 

biological products including human 

blood and blood components must 

comply with the applicable CGMP 

regulations (parts 211, 606, and 820 (21 

CFR parts 211, 606, and 820)) and 

current good tissue practice (CGTP) 

regulations (part 1271 (21 CFR part 

1271)) as appropriate. FDA regards 

biological product deviation (BPD) 

reporting and human cells, tissues, and 

cellular and tissue-based product (HCT/ 

P) deviation reporting to be an essential 

tool in its directive to protect public 

health by establishing and maintaining 

surveillance programs that provide 

timely and useful information. 

Section 600.14, in brief, requires the 

manufacturer who holds the biological 

product license, for other than human 

blood and blood components, and who 

had control over a distributed product 

when the deviation occurred, to report 

to the Center for Biologics Evaluation 

and Research (CBER) or to the Center for 

Drugs Evaluation and Research (CDER) 

as soon as possible but not to exceed 45 

calendar days after acquiring 

information reasonably suggesting that a 

reportable event has occurred. Section 

606.171, in brief, requires a licensed 

manufacturer of human blood and blood 

components, including Source Plasma; 

an unlicensed registered blood 

establishment; or a transfusion service 

who had control over a distributed 

product when the deviation occurred, to 

report to CBER as soon as possible but 

not to exceed 45 calendar days after 

acquiring information reasonably 

suggesting that a reportable event has 

occurred. Similarly, § 1271.350(b), in 

brief, requires non-reproductive HCT/P 

establishments described in § 1271.10 to 

report to CBER all HCT/P deviations 

relating to a distributed HCT/P that 

relates to the core CGTP requirements, 

if the deviation occurred in the 

establishment’s facility or in a facility 

that performed a manufacturing step for 

the establishment under contract, 

agreement or other arrangement. Form 

FDA 3486 is used to submit BPD reports 

and HCT/P deviation reports. 

Respondents to this collection of 

information are the licensed 

manufacturers of biological products 

other than human blood and blood 

components, licensed manufacturers of 

blood and blood components including 

Source Plasma, unlicensed registered 

blood establishments, transfusion 

services, and establishments that 

manufacture non-reproductive HCT/Ps 

regulated solely under section 361 of the 

PHS Act as described in § 1271.10. The 

number of respondents and total annual 

responses are based on the BPD reports 

and HCT/P deviation reports FDA 

received in fiscal year (FY) 2008. The 

number of licensed manufacturers and 

total annual responses under 21 CFR 

600.14 include the estimates for BPD 

reports submitted to both CBER and 

CDER. Based on the information from 

industry, the estimated average time to 

complete a deviation report is 2 hours. 

The availability of the standardized 

report form, Form FDA 3486, and the 

ability to submit this report 

electronically to CBER (CDER does not 

currently accept electronic filings) 

further streamlines the report 

submission process. 

CBER has developed an addendum to 

Form FDA 3486. The Web-based 

addendum 3486A provides additional 

information when a BPD report has been 

reviewed by FDA and evaluated as a 

possible recall. The additional 

information requested includes 

information not contained in the Form 

FDA 3486 such as: (1) Distribution 

pattern, (2) method of consignee 

notification, (3) consignee(s) of products 

for further manufacture, (4) additional 

product information, (5) updated 

product disposition, and (6) industry 

recall contacts. This information is 

requested by CBER through e-mail 

notification to the submitter of the BPD 

report. This information is used by 

CBER for recall classification purposes. 

At this time Addendum 3486A is being 

used only for those BPD reports 


emcdonald on DSK2BSOYB1PROD with NOTICES
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 


emcdonald on DSK2BSOYB1PROD with NOTICES