Walking as a Way for Americans To Get the Recommended Amount of Physical Activity for Health, 19491-19492 [2013-07204]

Download as PDF Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for information. pmangrum on DSK3VPTVN1PROD with NOTICES AGENCY: 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. VerDate Mar<15>2010 15:34 Mar 29, 2013 Jkt 229001 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 19491 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. E:\FR\FM\01APN1.SGM 01APN1 19492 Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices (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. pmangrum on DSK3VPTVN1PROD with NOTICES 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. VerDate Mar<15>2010 15:34 Mar 29, 2013 Jkt 229001 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: DATES: 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-to- PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 face 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 1 See http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ UCM281991.pdf. E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19491-19492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07204]


-----------------------------------------------------------------------

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 low-income 
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.

[[Page 19492]]

(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