Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 14405 

approval expires on February 28, 2014. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6092 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Patent Term Restoration, Due 

Diligence Petitions, Filing, Format, and 

Content of Petitions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Patent Term Restoration, Due Diligence 

Petitions, Filing, Format, and Content of 

Petitions’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

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 the 

Federal Register of January 12, 2011 (76 

FR 2127), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0233. The 

approval expires on February 28, 2014. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6091 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0122] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Focus Groups About Drug Products, 

as Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Focus Groups About Drug Products, as 

Used by the Food and Drug 

Administration’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

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 the 

Federal Register of July 9, 2010 (75 FR 

39541), the Agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0677. The 

approval expires on July 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: March 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6093 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No.FDA–2011–N–0085] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Cooperative Manufacturing 

Arrangements for Licensed Biologics 

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 proposed extension of the collection 

of information concerning the guidance 

for industry on cooperative 

manufacturing arrangements for 

licensed biologics. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 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– 

796–3794, 

Juanmanuel.Vilela@fda.hhs.gov. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
14406 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 

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. 

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 as follows: 

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 (FDA) remind the 

license manufacture 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 (21 CFR 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 

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, 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 14407 

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 No. 

0910–0116; § 610.2 has been approved 

under OMB Control No. 0910–0206; 

§§ 600.12(e) and 600.80 have been 

approved under OMB Control No. 

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), 660.35(c) 

through (g), 660.35(i) through (m), 

660.45, and 660.55(a) and (b) have been 

approved under OMB Control No. 

0910–0338; §§ 803.20, 803.50, and 

803.53 have been approved under OMB 

Control No. 0910–0437; and §§ 600.14 

and 606.171 have been approved under 

OMB Control No. 0910–0458. The 

current good manufacturing practice 

regulations for finished pharmaceuticals 

(part 211) have been approved under 

OMB Control No. 0910–0139; 

§§ 820.181 and 820.184 have been 

approved under OMB Control No. 

0910–0073; the establishment 

registration regulations (parts 207, 607, 

and 807) have been approved under 

OMB Control Nos. 0910–0045, 0910– 

0052, and 

0910–0387; and the labeling regulations 

(parts 201, 801, and 809) have been 

approved under OMB Control Nos. 

0910–0537, 0910–0572, and 0910–0485. 

Dated: February 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6055 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0109] 

Exchange of Letters Between Dr. 

Murray M. Lumpkin, Deputy 

Commissioner, International 

Programs, Food and Drug 

Administration and Mr. Martin 

Heraghty, Assistant Secretary General, 

Department of Agriculture, Fisheries 

and Food of Ireland Concerning 

Certification Requirements for 

Caseins, Caseinates, and Mixtures 

Thereof Exported From Ireland to the 

United States 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of exchange of letters between Dr. 

Murray M. Lumpkin, Deputy 

Commissioner, International and 

Special Programs, FDA and Mr. Martin 

Heraghty, Assistant Secretary General, 

Department of Agriculture, Fisheries 

and Food (DAFF), concerning 

certification requirements for caseins, 

caseinates, and mixtures thereof 

exported from Ireland to the United 

States. 

The mutual goals of FDA and DAFF 

in establishing certification 

requirements for caseins, caseinates, 

and mixtures thereof exported from 

Ireland to the United States are to assure 

that contaminated products will not be 

imported into the United States and to 

minimize the need for extensive FDA 

audit sampling of these products from 

Ireland. DAFF and FDA have a history 

of cooperation on this issue and it is, 

therefore, desirable that the two 

Agencies continue to cooperate to 

maintain and improve consumer 

protection. 

DATES: The agreement became effective 

November 10, 2010. 

FOR FURTHER INFORMATION CONTACT: 

David P. Kelly, Office of International 

Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 3404, Silver Spring, 

MD 20993–0002, 301–796–8373, Fax: 

301–595–7941. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and understandings between FDA and 

others shall be published in the Federal 

Register, the Agency is publishing 

notice of this agreement. 

Dated: March 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

BILLING CODE 4160–01–P 


jlentini on DSKJ8SOYB1PROD with NOTICES