48166 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: OIRA_SUBMISSION@OMB.eop.

gov, Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–19974 Filed 8–5–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0085] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Cooperative 

Manufacturing Arrangements for 

Licensed Biologics 

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 September 

7, 2011. 

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 0910–0629. Also 

include the FDA 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, 

juanmanuel.vilela@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. 

Guidance for Industry: Cooperative 

Manufacturing Arrangements For 

Licensed Biologics—(OMB Control 

Number 0910–0629)—Extension 

The guidance document provides 

information concerning cooperative 

manufacturing arrangements applicable 

to biological products subject to 

licensure under section 351 of the 

Public Health Service Act (42 U.S.C. 

262). The guidance addresses several 

types of manufacturing arrangements 

(i.e., short supply arrangements, divided 

manufacturing arrangements, shared 

manufacturing arrangements, and 

contract manufacturing arrangements) 

and describes certain reporting and 

recordkeeping responsibilities, 

associated with these arrangements, 

including the following: (1) Notification 

of all important proposed changes to 

production and facilities; (2) 

notification of results of tests and 

investigations regarding or possibly 

impacting the product; (3) notification 

of products manufactured in a contract 

facility; and (4) standard operating 

procedures. 

(1) Notification of All Important 

Proposed Changes to Production and 

Facilities 

Each licensed manufacturer in a 

divided manufacturing arrangement or 

shared manufacturing arrangement must 

notify the appropriate FDA center 

regarding proposed changes in the 

manufacture, testing, or specifications of 

its product, in accordance with § 601.12 

(21 CFR 601.12). In the guidance, we 

recommend that each licensed 

manufacturer that proposes such a 

change should also inform other 

participating licensed manufacturer(s) 

of the proposed change. 

For contract manufacturing 

arrangements, we recommend that the 

contract manufacturer should share 

with the license manufacturer all 

important proposed changes to 

production and facilities (including 

introduction of new products or at 

inspection). The license holder is 

responsible for reporting these changes 

to FDA (§ 601.12). 

(2) Notification of Results of Tests and 

Investigations Regarding or Possibly 

Impacting the Product 

In the guidance, we recommend the 

following for contract manufacturing 

arrangements: 

• The contract manufacturer should 

fully inform the license manufacturer of 

the results of all tests and investigations 

regarding or possibly having an impact 

on the product; and 

• The license manufacturer should 

obtain assurance from the contractor 

that any FDA list of inspectional 

observations will be shared with the 

license manufacturer to allow 

evaluation of its impact on the purity, 

potency, and safety of the license 

manufacturer’s product. 

(3) Notification of Products 

Manufactured in a Contract Facility 

In the guidance, we recommend for 

contract manufacturing arrangements 

that a license manufacturer cross 

reference a contract manufacturing 

facility’s Master Files only in 

circumstances involving certain 

proprietary information of the contract 

manufacturer, such as a list of all 

products manufactured in a contract 

facility. In this situation, the license 

manufacturer should be kept informed 

of the types or categories of all products 

manufactured in the contract facility. 

(4) Standard Operating Procedures 

In the guidance, we remind the 

license manufacturer that the license 

manufacturer assumes responsibility for 

compliance with the applicable product 

and establishment standards (21 CFR 

600.3(t)). Therefore, if the license 

manufacturer enters into an agreement 

with a contract manufacturing facility, 

the license manufacturer must ensure 

that the facility complies with the 

applicable standards. An agreement 

between a license manufacturer and a 

contract manufacturing facility normally 

includes procedures to regularly assess 

the contract manufacturing facility’s 

compliance. These procedures may 

include, but are not limited to, review 

of records and manufacturing deviations 

and defects, and periodic audits. 

For shared manufacturing 

arrangements, each manufacturer must 

submit a separate biologics license 

application (BLA) describing the 

manufacturing facilities and operations 

applicable to the preparation of that 

manufacturer’s biological substance or 

product (§ 601.2(a)). In the guidance, we 

state that we expect the manufacturer 

that prepares (or is responsible for the 

preparation of) the product in final form 

for commercial distribution to assume 

primary responsibility for providing 

data demonstrating the safety, purity, 

and potency of the final product. We 

also state that we expect the licensed 

finished product manufacturer to be 

primarily responsible for any postapproval obligations, such as 

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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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