37714 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 

children’s heart health, allocating 

resources for the campaign to provide 

support to overcome perceived barriers; 

Frequency of Response: One-time 

survey; Affected Public: Individuals or 

households; and Type of Respondents: 

Parents and caregivers of children ages 

0–7. The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 1,175; Estimated Number 

of Responses per Respondent: 1; 

Average Burden Hours per Response: 

.167; and Estimated Total Annual 

Burden Hours Requested: 196.23. There 

are no Capital Costs, Operating Costs 

and/or Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Amy Pianalto, 

National Heart, Lung, and Blood 

Institute, NIH, 31 Center Drive, Building 

31A, Room 4A10, Bethesda, MD 20892; 

or call non-toll-free number 301–594– 

2093 or e-mail request, including your 

address, to pianaltoa@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: July 21, 2009. 

Amy Pianalto, 

Office of Communications and Legislative 

Activities, NHLBI, National Institutes of 

Health. 

[FR Doc. E9–18071 Filed 7–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0097] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Request for 

Samples and Protocols 

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 August 28, 

2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0206. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

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 

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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 37715 

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, 

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 69 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2008, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 65 manufacturers 

submitted protocols under § 610.2 and 

21 CFR 610.3 manufacturers submitted 

protocols under the regulations 

(§§ 660.6 and 660.46) for the other 

specific products. FDA received no 

submissions under § 660.36; however, 

FDA is using the estimate of one 

protocol submission in the event one is 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2008, which totaled 

6,314, for the various submission 

requirements of samples and protocols 

for the licensed biological products. The 

rate of final actions is not expected to 

change significantly in the next few 

years. The hours per response are based 

on information provided by industry. 

The burden estimates provided by 

industry ranged from 1 to 5.5 hours. 

Under § 610.2, the hours per response 

are based on the average of these 

estimates and rounded to 3 hours. 

Under the remaining regulations, the 

hours per response are 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. 

In the Federal Register of March 6, 

2009 (74 FR 9820), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

610.2 65 95.5 6,208 3 18,624 

660.6(b) 2 44 88 5 440 

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

660.46(b) 1 17 17 5 85 

Total 69 6,314 19,155 

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

Dated: July 22, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17978 Filed 7–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0072] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RAPAFLO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

RAPAFLO and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

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