Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 48167 

postmarketing clinical trials, additional 

product stability studies, complaint 

handling, recalls, postmarket reporting 

of the dissemination of advertising and 

promotional labeling materials as 

required under § 601.12(f)(4) and 

adverse experience reporting. We 

recommend that the final product 

manufacturer establish a procedure with 

the other participating manufacturer(s) 

to obtain information in these areas. 

Description of Respondents: The 

recordkeeping and reporting 

recommendations described in this 

document affect the participating 

licensed manufacturer(s), final product 

manufacturer(s), and contract 

manufacturer(s) associated with 

cooperative manufacturing 

arrangements. 

Burden Estimate: We believe that the 

information collection provisions in the 

guidance do not create a new burden for 

respondents. We believe the reporting 

and recordkeeping provisions are part of 

usual and customary business practices. 

Licensed manufacturers would have 

contractual agreements with 

participating licensed manufacturers, 

final product manufacturers, and 

contract manufacturers, as applicable 

for the type of cooperative 

manufacturing arrangement, to address 

all these information collection 

provisions. 

The guidance also refers to previously 

approved collections of information 

found in FDA regulations at parts 201, 

207, 211, 600, 601, 606, 607, 610, 660, 

801, 803, and 807, 809, and 820 (21 CFR 

parts 201, 207, 211, 600, 601, 606, 607, 

610, 660, 801, 803, 807, 809, and 820). 

The collections of information in 

§§ 606.121, 606.122, and 610.40 have 

been approved under OMB control 

number 0910–0116; § 610.2 has been 

approved under OMB control number 

0910–0206; §§ 600.12(e) and 600.80 

have been approved under OMB control 

number 0910–0308; §§ 601.2(a), 601.12, 

610.60 through 610.65, 610.67, 660.2(c), 

660.28(a) and (b), 660.35(a), (c) through 

(g), and (i) through (m), 660.45, and 

660.55(a) and (b) have been approved 

under OMB control number 0910–0338; 

§§ 803.20, 803.50, and 803.53 have been 

approved under OMB control number 

0910–0437; and §§ 600.14 and 606.171 

have been approved under OMB control 

number 0910–0458. The current good 

manufacturing practice regulations for 

finished pharmaceuticals (part 211) 

have been approved under OMB control 

number 0910–0139; §§ 820.181 and 

820.184 have been approved under 

OMB control number 0910–0073; the 

establishment registration regulations 

(parts 207, 607, and 807) have been 

approved under OMB control numbers 

0910–0045, 0910–0052, and 0910–0387; 

and the labeling regulations (parts 201, 

801, and 809) have been approved 

under OMB control numbers 0910– 

0537, 0910–0572, and 0910–0485. 

In the Federal Register of March 16, 

2011 (76 FR 14405), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received from the public. 

Dated: August 2, 2011. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2011–19958 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0508] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Blood 

Establishment Registration and 

Product Listing, Form FDA 2830 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

relating to the blood establishment 

registration and product listing 

requirements in the Agency’s 

regulations and Form FDA 2830. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 7, 2011. 

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: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651. 

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, 

including each proposed extension of an 

existing 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. 

Blood Establishment Registration and 

Product Listing, Form FDA 2830—21 

CFR Part 607—(OMB Control Number 

0910–0052)—Extension 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360), any person owning or operating an 

establishment that manufactures, 

prepares, propagates, compounds, or 

processes a drug or device must register 

with the Secretary of Health and Human 

Services, on or before December 31 of 

each year, his or her name, place of 

business, and all such establishments, 

and must submit, among other 

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48168 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 

information, a listing of all drug or 

device products manufactured, 

prepared, propagated, compounded, or 

processed by him or her for commercial 

distribution. In part 607 (21 CFR part 

607), FDA has issued regulations 

implementing these requirements for 

manufacturers of human blood and 

blood products. 

Section 607.20(a), in brief, requires 

owners or operators of certain 

establishments that engage in the 

manufacture of blood products to 

register and to submit a list of every 

blood product in commercial 

distribution. Section 607.21, in brief, 

requires the owners or operators of 

establishments entering into the 

manufacturing of blood products to 

register within 5 days after beginning 

such operation and to submit a list of 

every blood product in commercial 

distribution at the time. If the owner or 

operator of the establishment has not 

previously entered into such operation 

for which a license is required, 

registration must follow within 5 days 

after the submission of a biologics 

license application. In addition, owners 

or operators of all establishments so 

engaged must register annually between 

November 15 and December 31 and 

must update their blood product listing 

information every June and December. 

Section 607.22 requires the use of Form 

FDA 2830 (Blood Establishment 

Registration and Product Listing) for 

initial registration, subsequent annual 

registration, and for blood product 

listing information. Section 607.25 sets 

forth the information required for 

establishment registration and blood 

product listing. Section 607.26, in brief, 

requires certain changes to be submitted 

on Form FDA 2830 as an amendment to 

establishment registration within 5 days 

of such changes. Section 607.30(a), in 

brief, sets forth the information required 

from owners or operators of 

establishments when updating their 

blood product listing information every 

June and December, or at the discretion 

of the registrant at the time the change 

occurs. Section 607.31 requires that 

additional blood product listing 

information be provided upon FDA 

request. Section 607.40, in brief, 

requires certain foreign blood product 

establishments to comply with the 

establishment registration and blood 

product listing information 

requirements discussed above and to 

provide the name and address of the 

establishment and the name of the 

individual responsible for submitting 

establishment registration and blood 

product listing information as well as 

the name, address, and phone number 

of its U.S. agent. 

Among other uses, this information 

assists FDA in its inspections of 

facilities, and its collection is essential 

to the overall regulatory scheme 

designed to ensure the safety of the 

nation’s blood supply. Form FDA 2830 

is used to collect this information. 

Respondents to this collection of 

information are human blood and 

plasma donor centers, blood banks, 

certain transfusion services, other blood 

product manufacturers, and 

independent laboratories that engage in 

quality control and testing for registered 

blood product establishments. 

FDA estimates the burden of this 

collection of information based upon 

information obtained from FDA’s Center 

for Biologics Evaluation and Research’s 

database and FDA experience with the 

blood establishment registration and 

product listing requirements. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Form FDA 2830 Number of 

respondents 

Number of 

responses 

per respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

607.20(a), 607.21, 607.22, 607.25, and 

607.40.

Initial Registration ....... 49 1 49 1 49 

607.21, 607.22, 607.25, 607.26, 607.31, and 

607.40.

Re-registration ............ 2,589 1 2,589 0 .5 1,294 

607.21, 607.25, 607.30(a), 607.31, and 

607.40.

Product Listing Update 180 1 180 0 .25 45 

Total ......................................................... ..................................... .................... .................... .................... .................... 1,388 

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

Dated: July 26, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–19955 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0126] 

Andrew K. Choi: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Andrew K. Choi, M.D. for 4 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on findings that Dr. Choi was 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

Dr. Choi was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Dr. 

Choi failed to respond. Dr. Choi’s failure 

to respond constitutes a waiver of his 

right to a hearing concerning this action. 

DATES: This order is effective August 8, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division of Compliance 

Policy (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

mstockstill on DSK4VPTVN1PROD with NOTICES