Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices 19491 

Review Officer, CDC, 4770 Buford 

Highway NE., Mailstop F–46, Atlanta, 

Georgia 30341, Telephone: (770) 488– 

3585, EEO6@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dana Redford, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2013–07443 Filed 3–29–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2013–0003] 

Walking as a Way for Americans To 

Get the Recommended Amount of 

Physical Activity for Health 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for information. 

SUMMARY: To address the public health 

problem of physical inactivity, the 

Centers for Disease Control and 

Prevention (CDC), within the 

Department of Health and Human 

Services (HHS) announces the opening 

of a docket to obtain information from 

the public on walking as an effective 

way to be sufficiently active for health. 

The information obtained will be used 

to frame an anticpated Surgeon 

General’s call to action on this issue. 

DATES: Individuals and organizations 

interested in providing information 

must submit their written comments on 

or before May 1, 2013. 

ADDRESSES: Comments may be 

submitted by any of the two following 

methods: 

• Internet: Electronic comments may 

be sent via: http://www.regulations.gov, 

docket number CDC–2013–0003. Please 

follow the instructions on the site to 

submit comments; or 

• Mail: Comments may also be sent 

by mail to the attention of Joan Dorn, 

Ph.D., Chief, Physical Activity and 

Health Branch, Division of Nutrition, 

Physical Activity, and Obesity, Centers 

for Disease Control and Prevention, 

4770 Buford Highway NE., MS–K46, 

Atlanta, Georgia, 30341–3717. 

Instructions: All information received 

in response to this notice must include 

the agency name and docket number 

(CDC–2013–0003). 

All relevant comments received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: Joan 

Dorn, Ph.D., Chief, Physical Activity 

and Health Branch, Division of 

Nutrition, Physical Activity, and 

Obesity, Centers for Disease Control and 

Prevention, 4770 Buford Highway NE., 

MS–K46, Atlanta, Georgia, 30341–3717 

by telephone (770–488–5692) or email 

(frnwalking@cdc.gov). 

SUPPLEMENTARY INFORMATION: 

Scope of the problem: Less than half 

(48%) of all U.S. adults (1) meet the 

2008 Physical Activity Guidelines, 

which will be included in the docket as 

a supporting document, and less than 3 

in 10 high school students get at least 

60 minutes of physical activity every 

day (2). Only 13 percent of children 

walk or bike to school, compared with 

44 percent a generation ago (3). More 

than a quarter of trips made by car are 

within one mile of home (4). Observed 

differences in physical activity levels 

among some population groups include: 

physical activity levels decline with age 

(5); activity levels are lower in lowincome communities and among racial/ 

ethnic miniorities (6); and, in general, 

persons with disabilities are less active 

than those without disabilities (7). 

Causes for lower physical activity levels 

vary but may in part be due to a lack 

of available and/or accessible places for 

safe and enjoyable physical activity. 

Walking can be an enjoyable 

recreational, occupational or purposeful 

(e.g., for transportation) physical 

activity in which many Americans can 

engage. It can enhance health and 

quality of life and can also serve as a 

gateway to other enjoyable types of 

physical activity. 

Approach: HHS/CDC works to 

increase health-related physical activity 

through population-based approaches. 

The agency also conducts physical 

activity related surveillance, applied 

research and evaluation, and translates 

and disseminates associated best 

practices to inform efforts to improve 

opportunities and support for physical 

activity. Consistent with these activities, 

HHS/CDC is assisting the Office of the 

Surgeon General in the Department of 

Health and Human Services to issue a 

call to action to increase attention to the 

promotion of walking and walkability to 

help Americans become more 

physically active. The intent of the 

Surgeon General’s call to action is to 

identify opportunities and actions that 

can be taken by all levels of government, 

civic organizations, health care 

providers, educational institutions, 

worksites, industry, service providers, 

individuals and others to increase 

walking and walkability throughout the 

nation by providing access to safe, 

attractive and convenient places to walk 

(and wheelchair roll) and creating a 

culture that supports walking for 

Americans of all ages and abilities. 

We invite comments and information 

on environmental or systems strategies; 

interventions that increase walkability 

of communities and walking for 

individuals; and national-, state-, 

tribal-, territorial-, community-, 

organizational-, and individual-level 

actions. We are particularly interested 

in strategies that consider individuals 

with developmental and chronic 

disease-related disabilities, and groups 

having health and physical activity 

disparities or lack resources and 

opportunities to be physically active. 

Areas of Focus: Many factors can 

contribute to low levels of walking and 

physical inactivity, including lack of 

access to safe and convenient places to 

walk, lack of signage and directional 

information, long distances to 

destinations, lack of public 

transportation, and lack of the inclusion 

of persons with mobility limitations in 

walking campaigns and programs. HHS/ 

CDC and the Office of the Surgeon 

General are interested in receiving 

information on the following topics: 

(1) Barriers to walking for youth; 

adults; seniors; persons with 

developmental, injury, and chronic 

disease-related disabilities; racial and 

ethnic minorities; and low-income 

individuals. 

(2) Evidence-based strategies for 

overcoming those barriers and their 

reach and impact to increase physical 

activity at the population level and 

among the above mentioned 

subpopulations. 

References 

(1) Schiller JD, Jucas JW, Ward BW, Peregoy 

JA. Summary health statistics for U.S. 

adults: National Health Interview 

Survey, 2010. Vital Health Stat 

2012;10(252). 

(2) CDC. Youth Risk Behavior Surveillance— 

United States, 2011. MMWR 2012;61(SS– 

4). 

(3) Centers for Disease Control and 

Prevention. The association between 

school based physical activity, including 

physical education, and academic 

performance. Atlanta, GA: U.S. 

Department of Health and Human 

Services; 2010. Available at http:// 

www.cdc.gov/healthyyouth/health_and_ 

academics/pdf/pa-pe_paper.pdf. 

Accessed May 17, 2011. 


pmangrum on DSK3VPTVN1PROD with NOTICES
19492 Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices 

1See http://www.fda.gov/downloads/Drugs/ 

DevelopmentApprovalProcess/ 

HowDrugsareDevelopedandApproved/ 

ApprovalApplications/ 

TherapeuticBiologicApplications/Biosimilars/ 

UCM281991.pdf. 

(4) Nationwide Personal Transportation 

Survey. U.S. Department of 

Transportation, Federal Highway 

Administration, Research and Technical 

Support Center. Lanham, MD: Federal 

Highway Administration, 1997. 

(5) Trost SG, Owen N, Bauman AE, et al. 

Correlates of adults’ participation in 

physical activity: Review and update, 

1996–2001. Med Sci Sports Exerc. 2002 

Dec;34(12). Available at http:// 

www.healthypeople.gov/2020/ 

topicsobjectives2020/ 

overview.aspx?topicid=33. Accessed 

May 16, 2011.; U.S. Department of 

Health and Human Services 2008 

Physical Activity Guidelines for 

Americans. Available from http:// 

www.health.gov/paguidelines. Accessed 

May 16, 2011. 

(6) Sallis JF, Prochaska JJ, Taylor WC. A 

review of correlates of physical activity 

of children and adolescents. Med Sci 

Sports Exerc. 2000; 32: 963–75. 

(7) Centers for Disease Control and 

Prevention. Physical activity among 

adults with a disability—United States 

2005. MMWR. 2007:56(39):1021–1024. 

Dated: March 18, 2013. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2013–07204 Filed 3–29–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0286] 

Draft Guidance for Industry on Formal 

Meetings Between FDA and Biosimilar 

Biological Product Sponsors or 

Applicants; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Formal Meetings 

Between the FDA and Biosimilar 

Biological Product Sponsors or 

Applicants.’’ This draft guidance 

provides recommendations to industry 

on formal meetings between FDA and 

sponsors or applicants relating to the 

development and review of biosimilar 

biological products regulated by the 

Center for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER). The 

guidance assists sponsors and 

applicants in generating and submitting 

a meeting request and the associated 

meeting package to FDA for biosimilar 

biological products. 

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 

either electronic or written comments 

on the draft guidance by May 31, 2013. 

Submit either electronic or written 

comments concerning the proposed 

collection of information by May 31, 

2013. 

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 Office 

of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Neel 

Patel, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6483, Silver Spring, 

MD 20993–0002, 301–796–0970; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

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 

‘‘Formal Meetings Between the FDA and 

Biosimilar Biological Product Sponsors 

or Applicants.’’ This draft guidance 

provides recommendations to industry 

on formal meetings between FDA and 

sponsors or applicants relating to the 

development and review of biosimilar 

biological products regulated by CDER 

and CBER. For the purposes of this draft 

guidance, ‘‘formal meeting’’ includes 

any meeting that is requested by a 

sponsor or applicant following the 

request procedures provided in this 

draft guidance and includes meetings 

conducted in any format (i.e., face-toface meeting, teleconference, or 

videoconference). 

The Biologics Price Competition and 

Innovation Act of 2009 amended the 

Public Health Service (PHS) Act and 

other statutes to create an abbreviated 

licensure pathway in section 351(k) of 

the PHS Act (42 U.S.C. 262(k)) for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological product (see 

sections 7001 through 7003 of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148)). The Biosimilar 

User Fee Act of 2012 (BsUFA), enacted 

as part of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144), amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to authorize a new user 

fee program for biosimilar biological 

products. FDA has committed to 

meeting certain performance goals in 

connection with the new user fee 

program. The performance goals, which 

are set forth in a letter from the 

Secretary of Health and Human Services 

to the Chairman of the Committee on 

Health, Education, Labor, and Pensions 

of the Senate and the Chairman of the 

Committee on Energy and Commerce of 

the House of Representatives,1 include 

meeting management goals for formal 

meetings that occur between FDA and 

sponsors or applicants during the 

development phase of a biosimilar 

biological product. This draft guidance 

describes the Agency’s current thinking 

on how it intends to interpret and apply 

certain provisions of BsUFA, and also 

provides information on specific 

performance goals for the management 

of meetings associated with the 

development and review of biosimilar 

biological products. 

This draft guidance reflects a unified 

approach to all formal meetings between 

sponsors or applicants and FDA for 

biosimilar biological product 

development (BPD) programs. It is 

intended to assist sponsors and 

applicants in generating and submitting 

a meeting request and the associated 

meeting package to FDA for biosimilar 

biological products. This draft guidance 

does not apply to new drug or 

abbreviated new drug applications 

under section 505 of the FD&C Act or 

to biologics license applications (BLAs) 

under section 351(a) of the PHS Act. 

FDA expects that review staff will 

participate in many meetings with 

biosimilar biological product sponsors 


pmangrum on DSK3VPTVN1PROD with NOTICES