32786 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Total .................................................................................................................................................................. 1,800,000 900,000 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: May 28, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–13728 Filed 6–8–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0019] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; General Licensing 

Provisions: Biologics License 

Application, Changes to an Approved 

Application, Labeling, Revocation and 

Suspension, Postmarketing Studies 

Status Reports, and Forms FDA 356h 

and 2567 

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 July 9, 

2010. 

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 0910–0338. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; General Licensing 

Provisions: Biologics License 

Application, Changes to an Approved 

Application, Labeling, Revocation and 

Suspension, Postmarketing Studies 

Status Reports, and Forms FDA 356h 

and 2567 (OMB Control Number 0910– 

0338)—Extension 

Under Section 351 of the Public 

Health Services Act (the PHS Act) (42 

U.S.C. 262), manufacturers of biological 

products must submit a license 

application for FDA review and 

approval before marketing a biological 

product in interstate commerce. 

Licenses may be issued only upon 

showing that the establishment and the 

products for which a license is desired 

meets standards prescribed in 

regulations designed to ensure the 

continued safety, purity, and potency of 

such products. All such licenses are 

issued, suspended, and revoked as 

prescribed by regulations in part 601 (21 

CFR Part 601). 

Section 130(a) of the Food and Drug 

Administration Modernization Act 

(Public Law 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding a new provision 

(section 506B of the act (21 U.S.C. 

356b)) requiring reports of 

postmarketing studies for approved 

human drugs and licensed biological 

products. Section 506B of the act 

provides FDA with additional authority 

to monitor the progress of postmarketing 

studies that applicants have made a 

commitment to conduct and requires 

the agency to make publicly available 

information that pertains to the status of 

these studies. Under section 506B(a) of 

the act, applicants that have committed 

to conduct a postmarketing study for an 

approved human drug or licensed 

biological product must submit to FDA 

a status report of the progress of the 

study or the reasons for the failure of the 

applicant to conduct the study. This 

report must be submitted within 1 year 

after the U.S. approval of the 

application and then annually until the 

study is completed or terminated. 

A summary of additional collection of 

information requirements follows. 

Section 601.2(a) requires a 

manufacturer of a biological product to 

submit an application on forms 

prescribed for such purposes with 

accompanying data and information, 

including certain labeling information, 

to FDA for approval to market a product 

in interstate commerce. The container 

and package labeling requirements are 

provided under §§ 610.60 through 

610.65. The estimate for these 

regulations is included in the estimate 

under § 601.2(a) in table 1 of this 

document. 

Section 601.5(a) requires a 

manufacturer to submit to FDA notice of 

its intention to discontinue manufacture 

of a product or all products. Section 

601.6(a) requires the manufacturer to 

notify selling agents and distributors 

upon suspension of its license, and 

provide FDA of such notification. 

Section 601.12 (a)(2) requires, 

generally, that the holder of an 

approved BLA must assess the effects of 

a manufacturing change before 

distributing a biological product made 

with the change. Section 601.12(a)(4) 

requires, generally, that the applicant 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 32787 

must promptly revise all promotional 

labeling and advertising to make it 

consistent with any labeling changes 

implemented. Section 601.12(a)(5) 

requires the applicant to include a list 

of all changes contained in the 

supplement or annual report; for 

supplements, this list must be provided 

in the cover letter. The burden estimates 

for § 601.12(a)(2) are included in the 

estimates for supplements (§§ 601.12(b) 

and (c)) and annual reports 

(§ 601.12(d)). The burden estimates for 

§ 601.12(a)(4) are included in the 

estimates under 601.12(f)(4) in table 1 of 

this document. 

Sections 601.12(b)(1) and (b)(3), (c)(1) 

and (c)(3), and (c)(5), and (d)(1) and 

(d)(3) require applicants to follow 

specific procedures to submit 

information to FDA of any changes, in 

the product, production process, quality 

controls, equipment, facilities, or 

responsible personnel established in an 

approved license application. The 

appropriate procedure depends on the 

potential for the change to have a 

substantial, moderate, or minimal 

adverse effect on the identity, strength, 

quality, purity, or potency of the 

products as they may relate to the safety 

or effectiveness of the product. Under 

§ 601.12(b)(4), an applicant may ask 

FDA to expedite its review of a 

supplement for public health reasons or 

if a delay in making the change 

described in it would impose an 

extraordinary hardship of the applicant. 

The burden estimate for § 601.12(b) (4) 

is minimal and included in the estimate 

under § 601.12(b)(1) and (b)(3) in table 

1 of this document. 

Section 601.12(e) requires applicants 

to submit a protocol, or change to a 

protocol, as a supplement requiring 

FDA approval before distributing the 

product. Section 601.12(f)(1), (f)(2), and 

(f)(3) requires applicants to follow 

specific procedures to report certain 

labeling changes to FDA. Section 

601.12(f)(4) requires applicants to report 

to FDA advertising and promotional 

labeling and any changes. 

Under section 601.14, the content of 

labeling required in § 201.100(d)(3) 

must be in electronic format and in a 

form that FDA can process, review, and 

archive. This requirement is in addition 

to the provisions of §§ 601.2(a) and 

601.12(f). The burden estimate for 

§ 601.14 is minimal and included in the 

estimate under §§ 601.2(a) (BLAs) and 

601.12(f)(1), (f)(2), and (f)(3) (labeling 

supplements and annual reports) in 

table 1 of this document. 

Section 601.45 requires applicants of 

biological products for serious or lifethreatening illnesses to submit to the 

agency for consideration, during the 

pre-approval review period, copies of all 

promotional materials, including 

promotional labeling as well as 

advertisements. 

In addition to §§ 601.2 and 601.12, 

there are other regulations in 21 CFR 

parts 640, 660, and 680 that relate to 

information to be submitted in a license 

application or supplement for certain 

blood or allergenic products as follows: 

§§ 640.6, 640.17, 640.21(c), 640.22(c), 

640.25(c), 640.56(c), 640.64(c), 

640.74(a), and (b)(2), 660.51(a)(4), 

680.1(b)(2)(iii), and 680.1(d). In table 1 

of this document, the burden associated 

with the information collection 

requirements in these regulations is 

included in the burden estimate for 

§§ 601.2 and/or 601.12. A regulation 

may be listed under more than one 

subsection of § 601.12 due to the type of 

category under which a change to an 

approved application may be submitted. 

There are also additional container 

and/or package labeling requirements 

for certain licensed biological products 

including: § 640.70(a) for Source 

Plasma; § 640.74(b)(3) and (4) for Source 

Plasma Liquid; § 640.84(a) and (c) for 

Albumin; § 640.94(a) for Plasma Protein 

Fraction; § 660.2(c) for Antibody to 

Hepatitis B Surface Antigen; § 660.28(a), 

(b), and (c) for Blood Grouping Reagent; 

§ 660.35(a), (c through g), and (i through 

m) for Reagent Red Blood Cells; § 660.45 

for Hepatitis B Surface Antigen; and 

§ 660.55(a) and (b) for Anti-Human 

Globulin. The burden associated with 

the additional labeling requirements for 

submission of a license application for 

these certain biological products is 

minimal because the majority of the 

burden is associated with the 

requirements under §§ 610.60 through 

610.65 or § 809.10. Therefore, the 

burden estimates for these regulations 

are included in the estimate under 

§§ 610.60 through 610.65 in table 1 of 

this document. The burden estimates 

associated with § 809.10 are approved 

under OMB Control No. 0910–0485. 

Section 601.25(b) requests interested 

persons to submit, for review and 

evaluation by an advisory review panel, 

published and unpublished data and 

information pertinent to a designated 

category of biological products that have 

been licensed prior to July 1, 1972. 

Section 601.26(f) requires that licensees 

submit to FDA a written statement 

intended to show that studies adequate 

and appropriate to resolve the questions 

raised about a biological product have 

been undertaken for a product if 

designated as requiring further study 

under the reclassification procedures. 

Under § 601.25(b), FDA estimates no 

PRA burden for this regulation, and 

therefore this regulation is not included 

in table 1 of this document. Under 

section 601.26(f), FDA estimates no 

burden for this regulation since there 

are no products designated to require 

further study and none are predicted in 

the future. However, FDA is using an 

estimate of 1 for calculation purposes. 

Based on the possible reclassification of 

a product, the labeling for the product 

may need to be revised, or a 

manufacturer, on its own initiative, may 

deem it necessary for further study. As 

a result, any changes to product labeling 

would be reported under the 

appropriate subsection of § 601.12. 

Section 601.27(a) requires that 

applications for new biological products 

contain data that are adequate to assess 

the safety and effectiveness of the 

biological product for the claimed 

indications in pediatric subpopulations, 

and to support dosing and 

administration information. Section 

601.27(b) provides that an applicant 

may request a deferred submission of 

some or all assessments of safety and 

effectiveness required under § 601.27(a) 

until after licensing the product for use 

in adults. Section 601.27(c) provides 

that an applicant may request a full or 

partial waiver of the requirements under 

§ 601.27(a) with adequate justification. 

The burden estimates for § 601.27(a) are 

included in the burden estimate under 

§ 601.2(a) in table 1 of this document 

since these regulations deal with 

information to be provided in an 

application. 

Section 601.28 requires sponsors of 

licensed biological products to submit 

the information in § 601.28(a), (b), and 

(c) to the Center for Biologics Evaluation 

and Research (CBER) or Center for Drug 

Evaluation and Research (CDER) each 

year, within 60 days of the anniversary 

date of approval of the license. Section 

601.28(a) requires sponsors to submit to 

FDA a brief summary stating whether 

labeling supplements for pediatric use 

have been submitted and whether new 

studies in the pediatric population to 

support appropriate labeling for the 

pediatric population have been 

initiated. Section 601.28(b) requires 

sponsors to submit to FDA an analysis 

of available safety and efficacy data in 

the pediatric population and changes 

proposed in the labeling based on this 

information. Section 601.28(c) requires 

sponsors to submit to FDA a statement 

on the current status of any 

postmarketing studies in the pediatric 

population performed by, on or behalf 

of, the applicant. If the postmarketing 

studies were required or agreed to, the 

status of these studies is to be reported 

under § 601.70 rather then under this 

section. 


erowe on DSK5CLS3C1PROD with NOTICES
32788 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

Sections 601.33 through 601.35 clarify 

the information to be submitted in an 

application to FDA to evaluate the 

safety and effectiveness of in vivo 

radiopharmaceuticals. The burden 

estimates for §§ 601.33 through 601.35 

are included in the burden estimate 

under § 601.2(a) in table 1 of this 

document since these regulations deal 

with information to be provided in an 

application. 

Section 601.70 (b) requires each 

applicant of a licensed biological 

product to submit annually a report to 

FDA on the status of postmarketing 

studies for each approved product 

application. Each annual postmarketing 

status report must be accompanied by a 

completed transmittal Form FDA 2252 

(Form FDA 2252 approved under OMB 

No. 0910–0001). Under § 601.70(d), two 

copies of the annual report shall be 

submitted to FDA. 

Section 601.91 through 601.94 

concerns biological products for which 

human efficacy studies are not ethical or 

feasible. Section 601.91(b)(3) requires 

applicants to prepare and provide 

labeling with relevant information to 

patient or potential patient for biological 

products approved under the subpart 

when human efficacy studies are not 

ethical or feasible (or based on evidence 

of effectiveness from studies in 

animals). Section 601.93 provides that 

biological products approved under this 

subpart are subject to the postmarketing 

recordkeeping and safety reporting 

applicable to all approved biological 

products. Section 601.94 requires 

applicants under this subpart to submit 

to the agency for consideration during 

preapproval review period copies of all 

promotional materials including 

promotional labeling as well as 

advertisements. 

Under § 601.93, any potential 

postmarketing reports and/or 

recordkeeping burdens would be 

included under the adverse experience 

reporting (AER) requirements under 21 

CFR part 600 (OMB Control No. 0910– 

0308). Therefore, any burdens 

associated with these requirements 

would be reported under the AER 

information collection requirements 

(OMB Control No. 0910–0308). 

Section 610.9(a) requires the 

applicant to present certain information, 

in the form of a license application or 

supplement to the application, for a 

modification of any particular test 

method or manufacturing process or the 

conditions which it is conducted under 

the biologics regulations. The burden 

estimate for § 610.9(a) is included in the 

estimate under §§ 601.2(a) and 601.12(b) 

and (c) in table 1 of this document. 

Section 610.11(g)(2) provides that a 

manufacturer of certain biological 

products may request an exemption 

from the general safety test (GST) 

requirements contained in this subpart. 

Under § 610.11(g)(2), FDA requires only 

those manufacturers of biological 

products requesting an exemption from 

the GST to submit additional 

information as part of a license 

application or supplement to an 

approved license application. Therefore, 

the burden estimate for § 610.11(g)(2) is 

included in the estimate under 

§§ 601.2(a) and 601.12(b) in table 1 of 

this document. 

Section 640.120 requires licensed 

establishments to submit a request for 

an exception or alternative to any 

requirement in the biologics regulations 

regarding blood, blood components, or 

blood products. A request for an 

exception or alternative must be 

submitted in accordance with § 601.12; 

therefore the burden estimate for 

§ 640.120 is included in the estimate 

under § 601.12(b) in table 1 of this 

document. 

Section 680.1(c) requires 

manufacturers to update annually their 

license file with the list of source 

materials and the suppliers of the 

materials. Section 680.1(b)(3)(iv) 

requires manufacturers to notify FDA 

when certain diseases are detected in 

source materials. 

Sections 600.15(b) and 610.53(d) 

require the submission of a request for 

an exemption or modification regarding 

the temperature requirements during 

shipment and from dating periods, 

respectively, for certain biological 

products. Section 606.110(b) requires 

the submission of a request for approval 

to perform plasmapheresis of donors 

who do not meet certain donor 

requirements for the collection of 

plasma containing rare antibodies. 

Under §§ 600.15(b), 610.53(d), and 

606.110(b), a request for an exemption 

or modification to the requirements 

would be submitted as a supplement. 

Therefore, the burden hours for any 

submissions under §§ 600.15(b), 

610.53(d), and 606.110(b) are included 

in the estimates under § 601.12(b) in 

table 1 of this document. 

In July 1997, FDA revised Form FDA 

356h ‘‘Application to Market a New 

Drug, Biologic, or an Antibiotic Drug for 

Human Use’’ to harmonize application 

procedures between CBER and CDER. 

The application form serves primarily as 

a checklist for firms to gather and 

submit certain information to FDA. The 

checklist helps to ensure that the 

application is complete and contains all 

the necessary information, so that 

delays due to lack of information may 

be eliminated. The form provides key 

information to FDA for efficient 

handling and distribution to the 

appropriate staff for review. The 

estimated burden hours for 

nonbiological product submissions to 

CDER using FDA Form 356h are 

approved under OMB Control No. 0910– 

0001. 

Form FDA 2567 ‘‘Transmittal of 

Labels and Circulars’’ is used by 

manufacturers of licensed biological 

products to submit labeling (e.g., 

circulars, package labels, container 

labels, etc.) and labeling changes for 

FDA review and approval. The labeling 

information is submitted with the form 

for license applications, supplements, or 

as part of an annual report. Form FDA 

2567 is also used for the transmission of 

advertisements and promotional 

labeling. Form FDA 2567 serves as an 

easy guide to assure that the 

manufacturer has provided the 

information required for expeditious 

handling of their labeling by CBER. For 

advertisements and promotional 

labeling, manufacturers of licensed 

biological products may submit to CBER 

either Form FDA 2567 or 2253. Form 

FDA 2253 was previously used only by 

drug manufacturers regulated by CDER. 

In August of 1998, FDA revised and 

harmonized Form FDA 2253 so the form 

may be used to transmit specimens of 

promotional labeling and 

advertisements for biological products 

as well as for prescription drugs and 

antibiotics. The revised, harmonized 

form updates the information about the 

types of promotional materials and the 

codes that are used to clarify the type of 

advertisement or labeling submitted; 

clarifies the intended audience for the 

advertisements or promotional labeling 

(e.g., consumers, professionals, news 

services); and helps ensure that the 

submission is complete. Form FDA 2253 

is approved under OMB Control No. 

0910–0001. 

Under table 1 of this document, the 

number of respondents is based on the 

estimated annual number of 

manufacturers that submitted the 

required information to FDA or the 

number of submissions FDA received in 

fiscal year (FY) 2008. Based on 

information obtained from FDA’s 

database systems, there are an estimated 

301 licensed biologics manufacturers. 

The total annual responses are based on 

the estimated number of submissions 

(i.e., license applications, labeling and 

other supplements, protocols, 

advertising and promotional labeling, 

notifications) for a particular product 

received annually by FDA. Based on 

previous estimates, the rate of 

submissions is not expected to change 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 32789 

significantly in the next few years. The 

hours per response are based on 

information provided by industry and 

past FDA experience with the various 

submissions or notifications. The hours 

per response include the time estimated 

to prepare the various submissions or 

notifications to FDA, and, as applicable, 

the time required to fill out the 

appropriate form and collate the 

documentation. Additional information 

regarding these estimates is provided 

below as necessary. 

Under §§ 601.2 and 601.12, the 

estimated hours per response are based 

on the average number of hours to 

submit the various submissions. The 

estimated average number of hours is 

based on the range of hours to complete 

a very basic application or supplement 

and a complex application or 

supplement. 

Under section 601.6(a), the total 

annual responses are based on FDA 

estimates that establishments may notify 

an average of 20 selling agents and 

distributors of such suspension, and 

provide FDA of such notification. The 

number of respondents is based on the 

estimated annual number of 

suspensions of a biologic license. 

Under §§ 601.12(f)(4) and 601.45, 

manufacturers of biological products 

may use either Form FDA 2567 or Form 

FDA 2253 to submit advertising and 

promotional labeling. Based on 

information obtained from FDA’s 

database system, there were an 

estimated 4,452 submissions of 

advertising and promotional labeling. 

FDA estimates that approximately 15% 

of those submissions were received with 

Form FDA 2567 and 85% were received 

with Form 2253. 

Under §§ 601.28 and 601.70(b), FDA 

estimates that it takes an applicant 

approximately 24 hours (8 hours per 

study x 3 studies) annually to gather, 

complete, and submit the appropriate 

information for each postmarketing 

status report (approximately two to four 

studies per report) and the accompanied 

transmittal Form FDA 2252. Included in 

these 24 hours is the time necessary to 

prepare and submit two copies of the 

annual progress report of postmarketing 

studies to FDA under § 601.70(d). 

Under §§ 601.91 through 601.94, FDA 

expects to receive very few applications 

for these products; however, for 

calculation purposes, FDA is estimating 

the annual submission of one 

application. Under §§ 601.93(b)(3) and 

601.94, FDA estimates 240 hours for a 

manufacturer of a new biological 

product to develop patient labeling, and 

to submit the appropriate information 

and promotional labeling to FDA. The 

majority of the burden for developing 

the patient labeling is included under 

the reporting requirements for § 601.94, 

therefore minimal burden is calculated 

for providing the guide to patients 

under § 601.91(b)(3). 

There were a total of 5,338 

amendments to an unapproved 

application or supplement and 

resubmissions submitted using Form 

FDA 356h. 

In the Federal Register of January 26, 

2010 (75 FR 4081), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received on this information collection 

request. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form FDA No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

601.2(a)2, 610.60 through 

610.653 2567/356h 23 2 46 860 39,560 

601.5(a) NA 11 3 33 20 minutes 11 

601.6(a) NA 1 21 21 20 minutes 7 

601.12(a)(5) NA 802 9 7,218 1 7,218 

601.12(b)(1)/(b)(3)/(e)4 356h 2 166 5 830 80 66,400 

601.12(c)(1)/(c)(3)5 356h 2 141 5 705 50 35,250 

601.12(c)(5) 356h 2 42 5 210 50 10,500 

601.12(d)(1)/(d)(3)/(f)(3)7 356h 2 246 3 738 23 16,974 

601.12(f)(1)6 2567 112 2 224 40 8,960 

601.12(f)(2)6 2567 53 3 159 20 3,180 

601.12(f)(4)/601.45 2567/2253 42 106 4,452 10 44,520 

601.26(f) NA 1 1 1 1 1 

601.27(b) NA 6 1 6 24 144 

601.27(c) NA 10 1 10 8 80 

601.70(b) and (d)/601.28 2252 39 2 78 24 1,872 

601.91(b)(3), 601.94 NA 1 1 1 240 240 

680.1(c) NA 9 1 9 2 18 

680.1(b)(3)(iv) NA 1 1 1 2 2 


erowe on DSK5CLS3C1PROD with NOTICES
32790 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section Form FDA No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Amendments/Resubmissions 356h 314 17 5,338 20 106,760 

TOTAL 341,697 

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

2The reporting requirements under §§ 610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c), 

640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a). 3The reporting requirements under §§ 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c), 

660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65. 4The reporting requirements under §§ 610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 

640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b). 5The reporting requirements under §§ 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under § 601.12(c). 6The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2). 

7The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3). 

Under table 2 of this document, the 

estimated recordkeeping burden of 1 

hour is based on previous estimates for 

the recordkeeping requirements 

associated with the AER (Adverse Event 

Reports) system. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

601.91(b)(2)(iii) 1 1 1 1 1 

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

Dated: June 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13815 Filed 6–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Discretionary Grant Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Noncompetitive 

Program Extension Supplemental 

Awards. 

SUMMARY: HRSA will be issuing noncompetitive supplemental funding 

under the Maternal Child and Health 

Bureau’s Family to Family Health 

Information Centers Program. This will 

provide feasible time for the Maternal 

and Child Health Bureau (MCHB) to 

align fiscal resources and programmatic 

goals as outlined in changes that 

emerged as a result of enactment of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) with the least 

disruption to the States, communities, 

and constituencies that currently 

receive assistance and services from 

these grantees. 

SUPPLEMENTARY INFORMATION: 

Intended Recipients of the Award: 

The 30 incumbent grantees (see list 

below). 

Amount of the Non-Competitive 

Supplemental Funding: $97,500 per 

grantee. 

Authority: Section 501(c)(1) of the 

Social Security Act, as amended. 

CFDA Number: 93.110. 

Project Period: June 1, 2010 through 

May 31, 2011 for a total of 12 months. 

Justification for the Exception to 

Competition 

The program provides grants to 

family-run/staffed organizations to 

ensure families of children with special 

health care needs have access to 

adequate information about health and 

community resources to allow informed 

decisions around their children’s health 

care. Family to Family Health 

Information Centers (F2F HICs) were 

originally authorized under the Family 

Opportunity Act as part of the Budget 

Deficit Reduction Act of 2005; Pub. L. 

109–171. Congress specified that there 

be a family-run/staffed center in each 

State and the District of Columbia by 

June 2009. These centers, among other 

tasks, were to assist families of children 

with special health care needs to make 

informed choices about health care in 

order to promote good treatment 

decisions, cost effectiveness and 

improved health outcomes by providing 

information and educational 

opportunities for families, their health 

professionals, schools, and other 

appropriate entities. Awards were 

staggered based upon available funding 

with 30 grantees awarded in 2007 with 

project periods ending May 31, 2010. As 

the end of their project period quickly 

approached and continued funding was 

not provided in the President’s Budget 

for fiscal year (FY) 2010, MCHB 

prepared for closeout of the program. 

Section 5507 of the Patient Protection 

and Affordable Care Act (the Affordable 

Care Act) extended the F2F HICs 

through FY 2012. Therefore, the MCHB 

will extend the project periods of the 30 

aforementioned grants into FY 2011. 

This will provide sufficient fiscal 

resources to continue programmatic 

activities as outlined in legislation with 

the least disruption to the States, 

communities, and the MCHB 

constituencies that currently receive 

assistance and services from these 

grantees. The MCHB will also delay the 

competition for these grants until FY 

2011 to ensure continuity of funding for 

all eligible entities, with no eligible 

entity being adversely impacted by the 

extension. 

FOR FURTHER INFORMATION CONTACT: 

LaQuanta Person, Project Officer, 

Integrated Services Branch, Division of 

Services for Children with Special 

Health Needs, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Room 18A–18, Rockville, MD 

20857; 301.443.2370; lperson@hrsa.gov. 


erowe on DSK5CLS3C1PROD with NOTICES