Attachment 2b 60day FRN comments

August 31, 2008

CDC Assistant Reports Clearance

Officer, 1600 Clifton Road, MS D–74,

Atlanta, GA 30333

Re: Proposed Data Collections Submitted for Public Comment and Recommendations

Dear Sir or Madam:

General Mills (GMI) is a Delaware Corporation with its general offices at No. 1 General Mills Boulevard, Minneapolis, MN 55426. GMI is a major packaged-food manufacturer engaged for over 75 years in the development and production of food products including flour, ready-eat-cereals, refrigerated dough products, cake and other dessert mixes, soups, vegetables, snacks and numerous other products.

GMI appreciates the opportunity to offer written comments concerning the Center for Disease Control’s (CDC) request for comments on proposed data collection projects.

GMI encourages increased funding of The National Health and Nutrition Examination Survey (NHANES).

General Mills is committed to delivering healthy food products and contributing to consumer understanding of health and nutrition. The General Mills Bell Institute of Health and Nutrition supports marketing efforts related to health, conducts scientific research, documents all health and nutrient content claims, conducts health professional outreach and manages regulatory and policy issues that affect the food industry.

Nutrition scientists at the General Mills Bell Institute of Health and Nutrition have been using National Nutrition Monitoring data since the 1970’s for a wide variety of functions including evaluation of the food supply, health communications, product guidance/support, regulatory issues and dietary intake research on the American population. NHANES data has practical utility and is a key resource for General Mills businesses and is leveraged in developing nutrition communications for consumers and health professionals, guiding product development and reformulation.

NHANES is invaluable in providing both the public and the private sectors with current and continuous measures of both food and nutrient intakes for the U.S. population as well as vital health tracking data such as obesity rates. Universal access to NHANES data facilitates the study of relationships between nutrition and many health outcomes in a representative sample of the United States. NHANES monitoring of the prevalence of chronic conditions and risk factors related to health such as arthritis, asthma, osteoporosis, infectious diseases, diabetes, high blood pressure, high cholesterol, obesity, smoking, drug and alcohol use, physical activity, environmental exposures, and diet provides an invaluable national resource. This continuous monitoring is increasingly more important as the food supply continues to change at a rapid pace. NHANES data are used to establish, monitor, and/or evaluate recommended dietary intake recommendations, food fortification policies, environmental exposures, immunization guidelines and health education and disease prevention programs.

Further, NHANES is a valuable resource for food manufacturers with applications in evaluating and developing comments, strengthening petitions to FDA on key regulatory issues and policies, targeting food products for specific populations, developing nutrition communications (packaging and otherwise) and evaluating food use for new product opportunities.

Future challenges for consumer foods companies include the growing diversity of the American population that is driving the need for more customization of food products, especially related to health. .

The CDC NCHS NHANES Web Site and the USDA Beltsville Human Nutrition Research Center/ Food Surveys Research Group Web Site are of enormous value in making the NHANES data and related research timely, accessible and affordable for researchers around the world and this monitoring system serves as a model for other countries.

GMI commends CDC on their efforts to seek comments on the utility of this program and strongly recommends the continuation of this program. We appreciate the opportunity to comment on this important issue, and look forward to working with the CDC in the future.

Respectfully submitted,

Ann M. Albertson, MS, RD

Senior Nutrition Research Scientist

General Mills Bell Institute of Health and Nutrition

James Ford Bell Technical Center 9000 Plymouth Avenue North Minneapolis, MN 55427

APIAHF ASIAN & PACIFIC ISLANDER AMERICAN HEALTH FORUM

September 3, 2008 CDC Assistant Reports Clearance Officer 1600 Clifton Road, MS D-74 Atlanta, GA 30333 Via email: [email protected] Subject: Proposed Data Collections Submitted for Public Comment and Recommendations; The National Health and Nutrition Examination Survey (NHANES) (0920-0237) - Revision – NCHS, CDC. To whom it may concern: In response to your call for comments, we respectfully submit our comments on the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS), National Health and Nutrition Examination Survey (NHANES) revision. The Asian & Pacific Islander American Health Forum (APIAHF) is a national advocacy organization dedicated to promoting policy, program, and research efforts to improve the health and well-being of Asian American, Native Hawaiian and Pacific Islander (AA & NHPI) communities. The inclusion of disaggregated data on Asian Americans, Native Hawaiians and Pacific Islanders (AA & NHPI) in all of the National Center for Health Statistics (NCHS) surveys is critical to achieving the policy goals outlined above in terms of helping to identify needs and advocate for allocation of resources on the community, local, state, and federal levels. Accurate and timely data are fundamental to identify and address the health and health care needs of Asian Americans, Native Hawaiians and Pacific Islanders. Researchers and community leaders have identified the lack of data, particularly data disaggregated by ethnicity and language, as a critical health policy issue. The lack of data disaggregated by AA & NHPI ethnic subgroups and by primary language renders invisible the disparities in health status and access that may be present for specific subgroups and languages. These data are essential to assure patient safety, effective quality improvement measures, enable appropriate distribution of resources, and eliminate the unnecessary burden of disease borne by these community members. The samples of Asian Americans, Native Hawaiians and Pacific Islanders are not reflective of all populations because of methodology issues, i.e. survey instruments are not often translated into appropriate languages primarily spoken by these populations (67% are limited English speakers); and the sample sizes of Asian Americans, Native Hawaiians and Pacific Islanders are too small to be statistically reliable and valid and are, therefore, not reported. AA & NHPI data are usually not available for most national health surveys due to sample size. We applaud the data collected thus far on a variety of nutrition, physical activity and overall health issues of the U.S. population. We hope that NHANES continues to collect such information so that more data is available on issues that affect our communities. Too often, to our detriment, AA & NHPI populations are left out of reports because sample sizes are not statistically significant or are lumped into the “other” category. Our populations are too diverse and heterogeneous with unique experiences and cultures to be lumped into such a category. We need such data samples to provide quantitative support for the qualitative evidence of health issues in our community. More so, we need such data to provide evidence for policy work and grant applications to then address such health issues. We support a number of recommendations that can improve data on Asian American, Native Hawaiian and Pacific Islander health collected via the NHANES. In order to ensure that information collected is necessary and useful; that the agency’s estimate of the burden is accurate; that the quality, utility and clarity of information is enhanced; and to minimize the burden of data collection on respondents, please take our recommendations into consideration. The NHANES website states that “The information gathered by NHANES provides a snapshot of the health and nutrition of the U.S. population. Because of this, persons in this survey are from a broad range of age groups and racial/ethnic backgrounds. Each participant represents approximately 50,000 other U.S. residents. The identities of our participants are held strictly confidential.” However, if NHANES data is not representative of all races, ethnicities and indigenous peoples of the United States in the data produced, than it is not truly representing the U.S. population. The AA & NHPI community is very heterogeneous with over 100 languages represented with 67% being limited English proficient. We recommend NHANES to hire bilingual interviewers or have interpreters available and to translate and administer the surveys in Asian languages. We also believe that oversampling and administering Community HANES in communities with significant numbers of specific AA and NHPI populations. For example: The Census Bureau also hires bilingual enumerators and enters into community partnerships to ensure an accurate county for the decennial Census. The National Health Interview Survey started oversampling for Asian populations in 2006. The California Health Interview Survey (CHIS) incorporates Korean and Vietnamese household oversamples and interviews in Chinese (Mandarin, Cantonese), Korean and Vietnamese languages. The Hawaii BRFSS and the Los Angeles County health survey also administer them in several Asian languages. NHANES interviews, health examinations, and the report of findings sent to participants will not be valuable to most AA & NHPI communities if conducted in English, because 67% of our populations are limited English proficient. We recommend that NCHS ensure that it is consistently implementing OMB guidance on the 1997 Standards for Federal Data on Race and Ethnicity. Additional guidance should also be provided on presenting data to ensure that publications that present findings by race explicitly state the reason for data not being represented for any one of the minimum five race categories. Similar to the standard used by Healthy People 2010 (e.g. DNA, DNC, DSU) that helps readers identify gaps in data and plan for future research needs. Please collect disaggregated data per the OMB categories and to report data analyses using at least the OMB categories for each of the racial/ethnic and indigenous groups. NCHS should address sample size deficiencies in existing surveys by pooling several years’ worth of data and bridging data from different surveys. This can boost sample size and enable disaggregation across subgroups (provided subgroup data was collected in the first place). NCHS should also provide guidance and conduct workshops for investigators to learn how to pool data and link existing databases. NCHS should develop guidance for bridging datasets and databases. For example, a collaboration of NCI, NCHS and University of Michigan researchers are exploring combining information from BRFSS and NHIS to obtain small area estimates. Combining estimation procedures from various surveys helps to address non-coverage and non-response issues and to estimate prevalence rates of other factors. We encourage NHANES to take specific actions to rectify the lack of data on Native Hawaiian and Pacific Islander health. Although the 1997 revision to the OMB Directive 15 established a category of “Native Hawaiian and Other Pacific Islander” separate from “Asian American,” there remains a lack of disaggregated data on the health of these communities. Evidence shows that this population has some of the worse health outcomes of all ethnic groups, but because of small sample size, insufficient resources are dedicated to improve their health status and access to care. For this past year, APIAHF, following up on a town hall meeting held in San Jose in the Fall of 2006 and a meeting with Secretary Leavitt in December 2006, worked with the Office of Minority Health to plan a town hall meeting in Carson, CA to further discuss Native Hawaiian and Pacific Islander health issues. APIAHF then co-hosted with The Native Hawaiian & Pacific Islander (NHPI) Alliance, the NHPI Health & Well Being Summit, which brought together 150 community members to Washington DC in order to dialogue within and beyond the community regarding NHPI health needs and to develop an action plan for a national health agenda. The major issue raised throughout these events was the lack of baseline disaggregated data on NHPI communities. A resolution, approved by a diverse group of Native Hawaiian and Pacific Islander organizations from the April 2007 Carson town hall states: “That the Native Hawaiian and Other Pacific Islanders are requesting that the collection of sufficient disaggregated data take place in areas with large Native Hawaiian and Other Pacific Islander populations; That the U.S. Department of Health and Human Services utilize the same methodology for the collection of sufficient disaggregated data as is used for other smaller ethnic groups such as the American Indian/Alaska Native, Hispanic Latinos and other special populations.” As participation in NHANES is voluntary, we recommend NHANES track if certain populations, i.e. specific racial, ethnic and indigenous populations are more or less likely to participate. Also, many immigrant populations may be fearful of participating in government studies that ask for personal information, therefore we encourage NHANES to pursue greater outreach in bilingual and culturally sensitive arenas. We are acutely aware that funding is a major issue for CDC, NCHS and the NHANES survey. APIAHF has joined with other public health advocacy organizations to support increased funding for NCHS, but we know that what was appropriated for this year is woefully inadequate to support NCHS’s existing projects. Conclusion Persistent issues of data content and survey design continue to leave AA & NHPI populations out of official national and state reports on health. This is still not acceptable. All of the communities that comprise AA & NHPI are growing and diversifying. Therefore, we must continue to make progress. On behalf of the Asian & Pacific Islander American Health Forum, I want to thank the NHANES for the opportunity to provide a written comment on the importance of Asian American, Native Hawaiian and Pacific Islander representation in our nation’s health statistical systems, specifically NHANES. We applaud the work of the National Center for Health Statistics and look forward to continuing to collaborate with them to compile the statistical information that most accurately represents our community, and truthfully documents our health needs. Sincerely, Roxanna Bautista, MPH, CHES Chronic Diseases Program Director

BOARD OF DIRECTORS 2008 Executive Committee Fatima Angeles, MPH Chairperson Dexter Louie, MD, JD, MPA Vice Chairperson Ho Luong Tran, MD, MPH President/Chief Executive Officer Dexter Louie, MD, JD, MPA Treasurer Janice Louie, RD, BSPH, MA Secretary Rea Pañares, MHS Member-at-large Wilson Wang, MD, MPA, MPH Member-at-large Vincent Hau, MD, PhD Senator Mee Moua Joyce O’Brien, MPH Sela Panapasa, PhD Headquarters: 450 Sutter Street Suite 600 San Francisco CA 94108 Main 415-954-9988 Fax 415-954-9999 www.apiahf.org Washington D.C. Office: 1828 L Street N.W. Suite 802 Washington, D.C. 20036 Main 202-466-7772 Fax 202-466-6444

National Advocates for

Asian American,

Native Hawaiian &

Pacific Islander Health

August 31, 2008

CDC Assistant Reports Clearance Officer

1600 Clifton Road

MS D-74

Atlanta, GA 30333

Submitted by email

RE: The National Health and Nutrition Examination Survey (NHANES) – (0920-0237) – Revision – National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC); 73 FR 38224 (July 3, 2008)

Dear Sir or Madam:

The National Fisheries Institute (NFI) appreciates the opportunity to comment on the proposed data collections for the National Health and Nutrition Examination Survey (NHANES) that was published in the Federal Register on July 3, 2008 (73 FR 38224) by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).

In the above mentioned notice, the Centers for Disease Control and Prevention (CDC) has requested comments on whether or not the proposed collection of information is necessary for the proper performance of the function of the agency.

The data collected in the past as part of the NHANES projects have proven to be valuable for government agencies, researchers and industry alike to gain a better understanding of the health and nutritional status of the U.S. population. Therefore, NFI supports the continuation of the data collection of the NHANES project.

In particular NFI supports the monitoring of blood mercury levels in young children and women of childbearing age in efforts to gain a better understanding of the impact of diet on blood mercury levels and subsequent impact on public health. In addition we support the continuation of the 2007 addition of measuring plasma omega-3 fatty acids in order to establish a better understanding of the dietary intake levels and potential deficiencies of this beneficial fatty acid.

Americans continue to be confused by the “risk or benefit” messages that they hear with regards to seafood consumption. Continuation of data collection on two of the important dietary pieces in this risk-benefit dialogue will further the research that supports regular fish consumption as an essential part of a healthy diet.

Additionally, emerging research is providing support that selenium may bind with mercury to negate its harmful effects. If not already included in the list of nutrients being tested, we suggest that it would be beneficial to also evaluate blood selenium levels to allow continued evaluation of the relationship between dietary selenium and mercury.

Thank you for the opportunity to provide our support for the continuation of the valuable NHANES data collection project. Please feel free to contact us if you have any questions.

Sincerely,

Lisa M. Weddig

Director, Regulatory and Technical Affairs

[email protected]

703-752-8886

The National Fisheries Institute (NFI) is the nation’s leading advocacy organization for the seafood industry. Its member companies represent every element of the industry, from the fishing vessels at sea to national seafood restaurant chains. From responsible aquaculture, to a marketplace supporting free trade, to ensuring consumers have the facts on the health benefits of fish and shellfish, NFI and its members support and promote sound public policy based on scientific research.

CDC Assistant Reports Clearing Officer

1600 Clifton Rd., MS D-74

Atlanta, GA 30333

Re: Proposed Data Collections Submitted for Public Comment and Recommendations: National Health and Nutrition Examination Survey [60Day-08-0237]

Dear Sir/Madam:

The Friends of NCHS appreciates the opportunity to submit comments to the Centers for Disease Control and Prevention (CDC) on the National Health and Nutrition Examination Survey (NHANES). The Friends of NCHS is a voluntary coalition of over 150 organizations and institutions that want to protect the National Center for Health Statistics (NCHS) and ensure the agency has a continued vital role in monitoring our nation’s health. Our diverse membership—major corporations, professional societies, trade associations, health plans, research institutions, and patient groups—demonstrates the sweeping support for and impact of the health data collected by NCHS (list attached).

NHANES is the premier survey of America’s health status, documenting major nutrition, infection, environmental, and chronic health conditions over time. It provides data that are essential for tracking the health and well being of the American population and informing evidence-based approaches for targeting public health and nutrition strategies. In addition, NHANES provides information necessary to inform nutrition labeling, fortification policies, food product development, and food marketing and education in the public and private sectors. And NHANES has been recognized as a shining example for collaborative work with other agencies and departments; cited by the Government Accountability Office in a 2005 report on results-oriented government and enhanced collaboration across federal agencies.1

Current funding levels for NCHS are precarious. Lost purchasing power due to years of flat funding and de facto funding decreases has jeopardized and compromised NCHS’s data collection activities, forcing the elimination of data collection and quality control efforts, threatening the collection of vital statistics, stymieing the adoption of electronic data collection systems, and limiting the agency’s ability to modernize surveys to reflect changes in demography, geography, and health delivery. Now the fate of NHANES hangs in the balance. Based on current budget projections, NCHS does not have the funding it needs to field NHANES in its current form. Without sufficient funding, NCHS will be forced to cut the NHANES sample size in half or take the survey out of the field altogether. At a minimum, the survey will

¹ Government Accountability Office. “Results Oriented Government: Practices That Can Help Enhance and Sustain Collaboration Among Federal Agencies” GAO-06-15. October 21, 2005

eliminate the practice oversampling of minority populations, which will compromise our understanding of health disparities at a time when our society becomes increasingly diverse.

² Institute of Medicine. Progress in Preventing Childhood Obesity Washington, DC: National Academies Press, 2006.

Compounding this troubling situation is the fact that federal agencies such as the National Institutes of Health and the Environmental Protection Agency provide nearly 30 percent of NHANES funding. If these agencies continue to receive flat or reduced funding, they are likely to withdraw much-needed support for NHANES, placing this national treasure at even greater risk.

A recent report from the Institute of Medicine recognized the importance of NHANES and called for the enhancement of current surveillance systems to monitor relevant outcomes and trends with respect to childhood obesity.2 As you consider revisions to the NHANES survey, it is imperative that all efforts be made to keep this population-based survey in tact and to maintain its scientific validity, quality, and integrity. Increased support of NHANES to maintain the robustness of the survey and avoid further cut-backs will allow the public health community to stem the tide against chronic disease, monitor our progress in fighting public health threats, and evaluate if public health dollars are targeted appropriately. If NHANES is compromised, we will lose our ability to track our progress in improving America’s health.

We hope these comments are useful as the agency continues to refine this survey and determine future needs. Please do not hesitate to contact me by phone at 202-292-6743 or by email at [email protected] should you have any questions.

² Institute of Medicine. Progress in Preventing Childhood Obesity Washington, DC: National Academies Press, 2006.

AARP

Abt Associates, Inc.

AcademyHealth

Alaska Native Tribal Health Consortium

Alliance for Aging Research

Alliance on Nutrition Monitoring

Alpha-1 Association

Alpha-1 Foundation

Altarum Institute

American Academy of Pediatrics

American Academy of Physician Assistants

American Association of Colleges of Nursing

American Association of Colleges of Pharmacy

American Association for Clinical Chemistry

American Association for Dental Research

American Association for Health Education

American Association for Respiratory Care

American Autoimmune Related Diseases Association

American Brain Coalition

American Cancer Society Cancer Action Network

American College of Clinical Pharmacy

American College of Emergency Physicians

American College of Healthcare Executives

American College of Nurse-Midwives

American College of Preventive Medicine

American Dental Education Association

American Dietetic Association

American Geriatrics Society

American Health Information Management Association

American Heart Association

American Medical Informatics Association

American Nurses Association

American Optometric Association

American Osteopathic Association

American Public Health Association

American Psychiatric Association

American Psychological Association

American Speech-Language-Hearing Association

American Society of Nephrology

American Society of Pediatric Nephrology

American Society for Reproductive Medicine

American Society for Nutrition

American Urological Association Foundation

American Thoracic Society

Aplastic Anemia & MDS International Foundation

The Arc of the United States

Arthritis Foundation

Asian & Pacific Islander American Health Forum

Association for Clinical Research Training

Association of American Medical Colleges

Association of Black Cardiologists, Inc.

Association of Maternal and Child Health Programs

Association of Minority Health Professions Schools

Association of Population Centers

Association of Public Health Laboratories

Association of State & Territorial Health Officials

Association of Women's Health, Obstetric, and Neonatal Nurses

Asthma and Allergy Foundation of America

Aveta, Inc.

Brown University, Warren Alpert Medical School, Center for Gerontology and Health Care Research

Building Bridges, Inc.

C3: Colorectal Cancer Coalition

Case Western Reserve University School of Medicine

Center for Science in the Public Interest

Children and Adults with Attention-Deficit/Hyperactivity Disorder

Coalition for the Advancement of Health through Behavioral and Social Sciences Research

Commonwealth of the Northern Mariana Islands Health and Vital Statistics Office

Congressional Black Caucus Foundation, Inc.

Consortium of Social Science Associations

COPD Foundation

Council of Professional Associations on Federal Statistics

Diabetes Action Research and Education Foundation

District of Columbia State Center for Health Statistics, Vital Records Division

Early Intervention Research Institute, Utah State University

Easter Seals

Emergency Medicine Network

Epilepsy Foundation of America

Fenway Community Health Center

Gay Men's Health Crisis, Inc.

General Mills

Grocery Manufacturers Association

Gundersen Lutheran Medical Center

Hadassah

Health Capital Consultants, LLC

Hearing Industries Association

Hearing Loss Association of America

Hirshberg Foundation for Pancreatic Cancer Research

Huntington's Disease Society of America

Infectious Diseases Society of America

Institute for the Advancement of Social Work Research

The Institute for Healthcare Quality Research and Education

International Waldenstrom's Macroglobulinemia Foundation

International & American Associations for Dental Research

Jacksonville Emergency Consultants, Inc.

The Jewish Guild for the Blind

Johns Hopkins University

The Joint Commission

Kidney Cancer Association

Kraft

Last Acts Partnership

Leonard Davis Institute of Health Economics

Lymphoma Foundation of America

March of Dimes Foundation

Maryland Department of Health and Mental Hygiene

Maryland Patient Advocacy Group

MATRIX Public Health Consultants, Inc.

Mental Health America

MJSahl Consulting

MMM Healthcare, Inc.

Musella Foundation for Brain Tumor Research & Information, Inc.

Medstat

The Melody Arons Center for Pre-School Research and Education

National Association for Public Health Statistics and Information Systems

National Committee for Quality Assurance

National Health Council

National Association of the Deaf

National Association of County and City Health Officials

National Business Group on Health

National Campaign to Prevent Teen Pregnancy

National Coalition for LGBT Health

National WIC Association

National Cued Speech Association

National Disability Sports Alliance

National Fragile X Foundation

National Health Law Program

National Hispanic Medical Association

National Hospice and Palliative Care Organization

National Multiple Sclerosis Society

National Organization for Hearing Research Foundation

National Osteoporosis Foundation

National Psoriasis Foundation

National Quality Forum

National Sleep Foundation

Nestle USA

North American Society for Pediatric Gastroenterology, Hepatology and Nutrition

NTM Info & Research, Inc.

Parent Project Muscular Dystrophy

Parkland Health and Hospital System

Pfeiffer University

Pituitary Network Association

Platelet Disorder Support Association

Post-Polio Health International

The Ohio State University College of Public Health

Partnership for Caring

Physicians for Human Rights

Population Association Of America

Prevent Blindness America

Public Health Foundation

Quality Community Health Care, Inc.

Research!America

RTI International

Service Employees International Union

Simmons School for Health Studies, Center for Health Policy Research

Snack Food Association

Society for Investigative Dermatology

Society for Neuroscience

Society for Women's Health Research

Southeast Emergency Consultants, Inc.

State and Territorial Injury Prevention Directors Association

Strategic Affairs Forecasting

Trust for America's Health

Tulane Center for Applied Environmental Public Health

UCB, Inc.

United Cerebral Palsy

University of California, San Francisco

The University of Georgia College of Pharmacy

University of Illinois at Chicago-School of Public Health

University of Michigan School of Public Health

University of Southern Maine, Institute for Health Policy, Muskie School of Public Service

University of Washington Department of Health Services

VHL Family Alliance

Virginia Commonwealth University, Department of Health Administration

Virginia Department of Health, Division of Health Statistics

Vision Council of America

WellPoint, Inc.

Well Spouse Association