Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 9663 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0114] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Request for 

Samples and Protocols 

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 regulations which state 

that protocols for samples of biological 

products must be submitted to the 

Agency. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 17, 2012. 

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: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@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 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. 

Request for Samples and Protocols— 

(OMB Control Number 0910–0206)— 

Extension 

Under section 351 of the Public 

Health Service Act (42 U.S.C. 262), FDA 

has the responsibility to issue 

regulations that prescribe standards 

designed to ensure the safety, purity, 

and potency of biological products and 

to ensure that the biologics licenses for 

such products are only issued when a 

product meets the prescribed standards. 

Under § 610.2 (21 CFR 610.2), the 

Center for Biologics Evaluation and 

Research (CBER) or the Center for Drug 

Evaluation and Research may at any 

time require manufacturers of licensed 

biological products to submit to FDA 

samples of any lot along with the 

protocols showing the results of 

applicable tests prior to distributing the 

lot of the product. In addition to § 610.2, 

there are other regulations that require 

the submission of samples and protocols 

for specific licensed biological products: 

§§ 660.6 (21 CFR 660.6) (Antibody to 

Hepatitis B Surface Antigen); 660.36 (21 

CFR 660.36) (Reagent Red Blood Cells); 

and 660.46 (21 CFR 660.46) (Hepatitis B 

Surface Antigen). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of a product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

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9664 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 77 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2011, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 73 manufacturers 

submitted protocols under § 610.2 and 2 

manufacturers submitted protocols 

under the regulation (§ 660.6) for the 

other specific product. FDA received no 

submissions under § 660.36 or § 660.46; 

however, FDA is using the estimate of 

one protocol submission under each 

regulation in the event that protocols are 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2011 for the various 

submission requirements of samples 

and protocols for the licensed biological 

products. The average burden per 

response is based on information 

provided by industry. The burden 

estimates provided by industry ranged 

from 1 to 5.5 hours. Under § 610.2, the 

average burden per response is based on 

the average of these estimates and 

rounded to 3 hours. Under the 

remaining regulations, the average 

burden per response is based on the 

higher end of the estimate (rounded to 

5 or 6 hours) since more information is 

generally required to be submitted in 

the other protocols than under § 610.2. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section No. of 

respondents 

No. of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2 .................................................................................... 73 92.9 6,782 3 20,346 

660.6(b) ................................................................................ 2 21.5 43 5 215 

660.36(a)(2) and (b) ............................................................. 1 1 1 6 6 

660.46(b) .............................................................................. 1 1 1 5 5 

Total .............................................................................. 77 ........................ 6,827 ........................ 20,572 

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

Dated: February 10, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3743 Filed 2–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Funds for Leadership Training in 

Pediatric Dentistry’s Current Grantees; 

One-Year Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of a Non-competitive 

One-Year Extension with Funds for 

Leadership Training in Pediatric 

Dentistry’s (T17) Current Grantees. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will be 

issuing a non-competitive one-year 

extension with funds for the Leadership 

Training in Pediatric Dentistry awards 

to Columbia University, The Regents of 

the University of California and the 

University of Washington. Up to 

$196,506 per grantee will be awarded 

over a one-year extended project period. 

The Leadership Training in Pediatric 

Dentistry program supports a national 

focus on leadership training in pediatric 

dentistry through the support of: (1) The 

postdoctoral training of dentists in the 

primary care specialty of pediatric 

dentistry for leadership roles in 

education, research, public health, 

advocacy, and public service related to 

oral health programs for populations of 

mothers and children (infants through 

adolescents), particularly children with 

special health care needs; (2) the 

development and dissemination of 

curricula, teaching models, and other 

educational resources to enhance 

maternal and child health (MCH) oral 

health programs; and (3) the continuing 

education, consultation, and technical 

assistance in pediatric oral health which 

address the needs of the MCH 

community. This extension with funds 

will allow HRSA’s Maternal and Child 

Health Bureau (MCHB) to align its 

leadership training initiatives in oral 

health with HRSA’s other oral health 

training investments. 

SUPPLEMENTARY INFORMATION: Grantees 

of record and intended award amounts 

are: 

Grantee/organization name Grant number State 

FY2011 

Authorized 

funding level 

FY2012 

Estimated 

funding level 

Columbia University ......................................................................... T17MC06359 ........................ NY $196,506 $196,506 

The Regents of the University of California, Los Angeles ............... T17MC08055 ........................ CA 196,506 196,506 

University of Washington ................................................................. T17MC00020 ........................ WA 196,506 196,506 

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