8966 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form Number No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

1040.30(c)(2) N/A 7 1 7 1 7 

1050.10(d)(1) through 

(d)(4) and (f)(1) 

through (f)(2)(iii) 

N/A 10 1 10 56 560 

Total Annual Reporting Burden 88,435 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record 

Total 

Hours 

1002.30 and 

1002.31(a) 1,150 1,655.5 1,903,825 0 .12 228,459 

1002.40 and 

1002.41 2,950 49.2 145,140 0 .05 7,257 

1020.30(g) 22 1 22 0 .5 11 

1040.10(a)(3)(ii) 40 1 40 1 .0 40 

Total 235,767 

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

The burden estimates were derived by 

consultation with FDA and industry 

personnel, and are based on actual data 

collected from industry. An evaluation 

of the type and scope of information 

requested was also used to derive some 

time estimates. For example, disclosure 

information primarily requires time 

only to update and maintain existing 

manuals. Initial development of 

manuals has been performed except for 

new firms entering the industry. 

The following information collection 

requirements are not subject to review 

by OMB because they do not constitute 

a ‘‘collection of information’’ under the 

PRA: Sections 1002.31(c); 1003.10(a), 

(b), and (c); 1003.11(a)(3) and (b); 

1003.20(a) through (h); 1003.21(a) 

through (d); 1003.22(a) and (b); 

1003.30(a) and (b); 1003.31(a) and (b); 

1004.2(a) through (i); 1004.3(a) through 

(i); 1004.4(a) through (h); 1005.21(a) 

through (c), and 1005.22(b). These 

requirements apply to the collection of 

information during the conduct of 

general investigations or audits (5 CFR 

1320.4(b)). 

The following labeling requirements 

are also not subject to review under the 

PRA because they are a public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public (5 CFR 

1320.3(c)(2)): Sections 1020.10(c)(4), 

1030.10(c)(6), 1040.10(g), 1040.30(c)(1), 

and 1050.10(d)(1). 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4002 Filed 2–25–10; 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 providing 

extensions with funds ranging from 5 to 

10 months to program grantees for the 

following programs in order to bring 

these programs into alignment with 

changes resulting from HRSA’s Maternal 

and Child Health Bureau’s developing 

strategic plan and the Early Learning 

and Development Initiative of the HHS 

and Department of Education. The 

programs are: 

• Alliance for Information in Maternal 

and Child Health (AIM) 

Æ Improving Understanding of 

MCH—10 grants 

Æ Partnerships to Promote MCH—5 

grants 

• AIM Policy Center—1 grant 

• Mental Health and Schools Resource 

Centers—2 grants 

• Public Policy Analysis and Education 

Center for Early Childhood—1 grant 

• National Healthy Child Care America 

Program 

Æ National Training Institute for 

Health Consultants—1 grant 

Æ Child Care Health Partnership 

Program—1 grant 

Æ Resource Center for Childcare 

Health and Safety—1 grant 

• National Sudden and Unexpected 

Infant/Child Death and Pregnancy 

Loss Centers—3 grants 

SUPPLEMENTARY INFORMATION: 

Intended Recipients of the Award 

The intended recipients are the 

incumbent grantees. They are either 

national membership organizations 

whose members impact maternal and 

child health programming or 

institutions of higher learning. They 

share a common purpose of providing 

education and technical assistance to 

either their individual members or State 

and community Maternal and Child 

Health programs. 

Authority: Section 501(a) (3) of the Social 

Security Act, as amended 

CFDA Number: 93.110. 

Project Period: The period of 

supplemental support is from the 

grantee’s original project end date 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8967 

through January 31, 2011. The periods 

range from 5 to 10 months. 

Grantees and Amount of the Awards: 

See listing below. 

HRSA Competition Name and Announcement Number Grant number Project period FY 2009 authorized 

funding 

level 

Revised project 

end date 

Supplemental 

funding 

Organization Name 

Alliance for Information on Maternal and Child Health (AIM) Improving Understanding of Maternal and Child Health and Health Care 

Issues, HRSA–05–079 

National Conference of State Legislatures.G96MC04443 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Conference of State Legislatures.G96MC04444 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Association of State and Territorial 

Health Officials.

G96MC04445 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Institute for Health Care Management.G96MC04446 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Business Group on Health ..... G96MC04447 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Grantmakers in Health .......................... G96MC04448 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Association of County and 

City Health Officials.

G96MC04449 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Governors Association ........... G96MC04450 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

American Bar Association ..................... G96MC04451 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Grantmakers for Children, Youth and 

Families.

G96MC04452 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Alliance for Information on Maternal and Child Health (AIM) Partnerships to Promote Maternal and Child Health, HRSA–05–076 

Family Voices, Inc. ............................... G97MC04453 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Today’s Child Communications, Inc. .... G97MC04454 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

American Academy of Pediatric Dentistry.G97MC04455 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

National Healthy Start Association, Inc. G97MC04488 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

American Academy of Pediatrics .......... G97MC06336 ........ 1–May-05—30–Apr-10 ............ $200,000 31–Jan-11 ....... $150,000 

Alliance for Information on Maternal and Child Health (AIM) Child and Adolescent Policy Support Center, HRSA–07–041 

The Regents of the University of California.U45MC08263 ........ 1–Jul-07- 30–Jun-10 ................ $300,000 31–Jan-11 ....... $175,000 

School Mental Health Program and Policy Analysis Centers, HRSA–05–034 

University of Maryland, Baltimore ......... U45MC00174 ........ 1–Jul-05—30–Jun-10 .............. $400,000 31–Jan-11 ....... $233,333 

The Regents of the University of California.U45MC00175 ........ 1–Jul-05—30–Jun-10 .............. $400,000 31–Jan-11 ....... $233,333 

Public Policy Analysis and Education Center for Early Childhood Health Cooperative Agreement, HRSA–05–115 

Columbia University .............................. U05MC05056 ........ 1–Jul-05—30–Jun-10 .............. $350,000 31–Jan-11 ....... $204,167 

National Healthy Child Care America Cooperative Agreement Program, HRSA–05–058 

University of North Carolina at Chapel 

Hill.

U46MC00003 ........ 1–Oct-97—31–Mar-10 ............. $350,000 31–Jan-11 ....... $291,667 

American Academy of Pediatrics .......... U46MC04436 ........ 1–Apr-05—31–Mar-10 ............. $350,000 31–Jan-11 ....... $291,667 

University of Colorado Health Sciences 

Center.

U46MC09810 ........ 1–Apr-08—31–Mar-10 ............. $375,000 31–Jan-11 ....... $312,500 

Sudden Infant Death Syndrome Cooperative Agreement Program, HRSA–05–100 

Association of SIDS and Infant Mortality Programs.U48MC05548 ........ 1–Sep-05—31–Aug-10 ............ $200,000 31–Jan-11 ....... $83,333 

The Sudden Infant Death Syndrome 

Alliance.

U48MC05549 ........ 1–Sep-05—31–Aug-10 ............ $250,000 31–Jan-11 ....... $104,167 

National SIDS Infant Death Resource Center, HRSA–07–040 

Georgetown University .......................... U48MC08717 ........ 1–Sep-07—31–Aug-10 ............ $350,000 31–Jan-11 ....... $145,833 

FOR FURTHER INFORMATION CONTACT: 

David Heppel, Director, Division for 

Child, Adolescent and Family Health, 

Health Resources and Services 

Administration, Maternal and Child 

Health Bureau, 5600 Fishers Lane, 

Room 18A39, Rockville, MD 20857, 

301.443.2250; dheppel@hrsa.gov. 


sroberts on DSKD5P82C1PROD with NOTICES
8968 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

Justification for the Exception to 

Competition 

The reason for this exception is to 

allow sufficient time for the HRSA’s 

Maternal and Child Health Bureau 

(MCHB) to align its fiscal resources and 

programmatic goals: 

• With the developing Maternal and 

Child Health Strategic Plan and with 

HRSA and Departmental plans; and, 

• With the Early Learning and 

Development Initiative of the 

Department of Health and Human 

Services and the Department of 

Education; and, to maintain during this 

transition period MCH programmatic 

support to the State and community 

MCH constituencies which currently are 

receiving technical assistance services 

from these MCHB grantees. 

The activities listed in the previous 

paragraph will not be completed in time 

for the FY 2010 grant competition. The 

MCHB proposes, therefore, to extend 

into FY 2011 the project periods of 

those grants scheduled to conclude in 

FY 2010 in order to have a larger and 

more current grant competition in FY 

2011 reflective of any and all 

programmatic changes resulting from 

the above referenced activities and 

actions. Delaying the competition into 

FY 2011 also allows the MCHB 

additional time to consult with and 

provide information to constituency 

groups about changes in program 

direction. Providing an extension with 

funds to these grantees through January 

31, 2011, will ensure the provision of 

technical assistance to the affected MCH 

constituencies continues without 

disruption. 

Dated: February 9, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–3886 Filed 2–25–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0090] 

Draft Guidance for Industry on 

Adaptive Design Clinical Trials for 

Drugs and Biologics; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Adaptive Design Clinical Trials for 

Drugs and Biologics.’’ The draft 

guidance provides sponsors and the 

review staff in FDA’s Center for Drug 

Evaluation and Research (CDER) and 

Center for Biologics Evaluation and 

Research (CBER) with information 

regarding adaptive design clinical trials 

when used in drug development 

programs. The draft guidance gives 

advice on various topics, such as what 

aspects of adaptive design clinical trials 

(i.e., clinical, statistical, regulatory) call 

for special consideration, when to 

interact with FDA while planning and 

conducting adaptive design studies, 

what information to include in the 

adaptive design for FDA review, and 

issues to consider in the evaluation of 

a completed adaptive design study. The 

draft guidance is intended to assist 

sponsors in planning and conducting 

adaptive design clinical studies, and to 

facilitate an efficient FDA review. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 1, 2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or to the 

Office of Communication, Outreach and 

Development, 1401 Rockville Pike, suite 

200N, Rockville, MD 20852–1448. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 301–827–1800. 

Submit written comments on the draft 

guidance 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert T. O’Neill, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3554, 

Silver Spring, MD 20993–0002, 301– 

796–1700; or 

Sue-Jane Wang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3554, 

Silver Spring, MD 20993–0002, 301– 

796–1700; or 

Marc Walton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4524, 

Silver Spring, MD 20993–0002, 301– 

796–2600; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852– 

1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Adaptive Design Clinical Trials for 

Drugs and Biologics.’’ This guidance 

provides information regarding adaptive 

design trials when used in drug 

development programs. 

There is great interest in the 

possibility that clinical trials can be 

designed with ‘‘adaptive’’ features (i.e., 

changes in design or analyses guided by 

examination of the accumulated data at 

an interim point in the trial) that can 

make the studies more efficient (e.g., 

shorter duration, fewer patients), more 

likely to demonstrate an effect of the 

drug if one exists, or more informative 

(e.g., by providing broader doseresponse information). The draft 

guidance discusses clinical, statistical, 

and regulatory aspects of a wide range 

of adaptive design clinical studies that 

can be proposed as part of a drug 

development program, including both 

familiar and less familiar approaches. 

As more experience is obtained with the 

less familiar designs, sponsors can 

improve their understanding of 

circumstances where these designs are 

most useful or may pose risks to study 

integrity and interpretation. The draft 

guidance describes aspects of adaptive 

design trials that deserve special 

consideration and provides advice on 

the information that should be provided 

to FDA and how best to interact with 

FDA to facilitate an efficient review. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on adaptive design clinical trials for 

drugs and biologics. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal agencies must obtain 


sroberts on DSKD5P82C1PROD with NOTICES