0920-0469_NPCR-CSS_Supporting Statement A_5-4-22

Goal: The goal of the project is to continue collection of cancer occurrence and outcomes in the United States under the National Program of Cancer Registries (NPCR).

Intended Use: The data will be used to: track cancer incidence at national, state, and county levels; identify disparities in burden of disease; assess success of public health screening and other intervention programs; and assess quality of care.

Data Collection Methods: Data are reported to CDC by NPCR-supported central cancer registries. Reporting to central cancer registries by hospital and other care providers is required by state legislation. The information collection includes all cancers.

Study Population: All populations can be studied.

Analysis: Analysis includes cancer incidence rates, Joinpoint trends, survival, and prevalence estimates, using SEER*STAT and other standard epidemiologic methods including logistic regression.

A.1 Circumstances Making the Collection of Information Necessary

In 2018, the most recent year for which complete incidence information is available, more than 1.7 million were diagnosed with cancer and almost 600,000 people died of cancer (1). It is estimated that 16.3 million Americans are currently alive with a history of cancer (2). In the U.S., state/territory-based central cancer registries are the only method for systematically collecting and reporting population-based information about cancer incidence and outcomes such as survival. These data are used to measure the changing incidence and burden of each cancer; identify populations at increased or increasing risk; target preventive measures; and measure the success or failure of cancer control efforts in the U.S.

Cancer registration depends upon Central Cancer Registries (CCRs), funded primarily by CDC’s National Program of Cancer Registries (NPCR). NPCR was established in 1992 when Congress enacted the Cancer Registries Amendment Act, Public Law 102-515 (Attachment 1a), later incorporated into the Public Health Service (PHS) Act [42 U.S.C. 242k]. Congressional appropriations have been provided for the NPCR since its inception in 1992. In fiscal year 2021, CDC awarded about $39 million through cooperative agreements to assist in funding central cancer registry operations in 46 states, the District of Columbia, Puerto Rico, U.S. Virgin Islands, and the Pacific Island Jurisdictions. Information is collected and maintained at CDC under Section 301 of the Public Health Service (PHS) Act [42 U.S.C. 242k] (Attachment 1b). NPCR captures cancer in 97% of the U.S population. State collection is conducted under the authority of state laws in all 50 states which require reporting of cancer data to the CCR. The same is true for the District of Columbia, the Pacific Islands Jurisdiction, U.S. Virgin Islands, and Puerto Rico and all additional references to states include these areas as well.

The CCR receives data from hospitals, pathology laboratories, and providers who provide cancer diagnosis or treatment. The data are collected on all cancer diagnoses and include type of cancer, stage, age, race, ethnicity, initial type of treatment received, and vital status. The CCRs then aggregate the data and use the information for activities such as state and county cancer reports, implementation of screening interventions, and cancer cluster investigations. An overview of data collection and flow is provided in Attachment 2.

These same data are collected within the NPCR-funded CCR regardless of the data submission to CDC. Uniform standards for cancer reporting are developed collaboratively by state CCRs, various organizations in the oncology community (e.g., American College of Surgeon’s Commission on Cancer, American Joint Committee on Cancer), the National Cancer Institute and CDC. These collaborative standards are operationalized and disseminated by the North American Association of Central Cancer Registries (NAACCR) (www.naaccr.org), a professional organization that formalizes and disseminates the data standards for cancer registration across all of North America. Cancer registry standards are regularly reviewed and updated by NAACCR.

Data submission from states to CDC is electronic and requires minimal additional effort from the CCR. All records are de-identified before submission to CDC so that neither CDC nor any researcher is able to identify a cancer patient. Information in identifiable form (IIF) is reported to CDC including height, weight, date of birth, and medical information about the types of cancer that occur (histology, morphology, and behavior), the anatomic location, the extent of disease at the time of diagnosis, the kinds of treatment received by cancer patients, and the outcomes of treatment and clinical management.

Since 2000, NPCR funded CCRs to report specific and standardized data elements to CDC as a function of the National Program of Cancer Registries Cancer Surveillance System (NPCR CSS), OMB No. 0920-0469 which expires: 12/31/2022. Attachment 3a is a list of data items for each of the two planned data submissions – preliminary and final (see Section A16). This table is based on the most recent NAACCR Standards for Cancer Registries, Volume II (3). Attachment 3b summarizes the changes to the NPCR CSS Submission Specifications data elements.

CDC requests OMB approval for three years to extend the NPCR CSS information collection, with changes limited to data variable updates as defined by the professional cancer registry coding standards. No changes to the total estimated annualized burden hours or number of respondents are anticipated.

A.2 Purpose and Use of the Information Collected

This request is to revise the NPCR-CSS to include an update of data definitions that reflect changes in national standards for cancer diagnosis, treatment, and coding. The North American Association of Central Cancer Registries (3) periodically updates the standardized data layout to reflect changes in cancer staging or other changes in data definitions considered necessary to collect accurate data on cancer incidence. These changes will affect the standard reports for all NPCR-funded CCRs. Attachment 3b summarizes the changes to the NPCR-CSS required data elements for the standard report.

CDC does not receive patient names, addresses, or Social Security Numbers. Confidentiality and privacy are of paramount concern to the NPCR because of the confidentiality concerns of the awardees, the private nature of medical data in a cancer surveillance database, and the potential for direct and deductive identification of an individual in the NPCR CSS. After extensive discussions with the CDC Privacy Officer, CDC obtained an Assurance of Confidentiality (308(d)) on June 7, 2000, with multiple renewals, the most recent in 2020 (Attachment 4).

CDC combines the de-identified data received from the 50 NPCR registries with data from the National Cancer Institute (NCI)-funded Surveillance Epidemiology and End Results (SEER) registries to provide complete National data on cancer. To reduce the nation's cancer burden, behavioral and environmental factors that increase cancer risk must be reduced, and high‑quality screening services and evidence‑based treatments must be available and accessible, particularly to medically underserved populations (4). The availability of complete and accurate cancer data at the National, state, and local level facilitates identification of disparities in cancer incidence and treatment, which supports targeted interventions such as screening or education to reduce the morbidity and mortality from cancer. The impact of prevention and early detection measures can also be monitored and measured through state cancer registries since they are designed to monitor cancer trends over time, determine cancer patterns in various populations, and guide planning and evaluation of cancer control programs.

The public and researchers have access to this de-identified data via CDC websites and can assess cancer incidence rates overall or for particular cancers, races, or age groups. These public-use data sets are comprised of aggregated data (i.e., not individual case-specific data) that have been modified as needed, according to accepted procedures, to block breaches of confidentiality and prevent disclosure of the patients’ confidential information (5-7). More detailed data are also provided through procedures that ensure the privacy and protection of the individuals whose data are included. A copy of CDC’s data release policy is provided in Attachment 5. CDC’s Division of Cancer Prevention and Control (DCPC) has worked with the National Center for Health Statistics Research Data Center (NCHS RDC) to host the NPCR data to allow researchers outside of CDC access in a secure environment without jeopardizing the confidentiality of the data (8). Users must have a protocol reviewed and approved and must sign data use agreements. Data users within CDC must also sign data use agreements which require them to meet all privacy requirements necessary to prevent accidental or intentional disclosures.

In addition to the data files available through the NCHS RDC, and in compliance with assuring that data are publicly available, a subset of de-identified case-specific data are publicly available through NCI’s statistical analytic software SEER*Stat (https://seer.cancer.gov/seerstat). This data has additional aggregation, restrictions, and exclusions applied for further protection of confidentiality. For example, full dates are excluded from the dataset, cell suppression for counts <16 are enforced within the software, and the software’s case listing (case export) function is disabled. Access requires the user to sign data use agreements with CDC and NCI.

Numerous scientific publications and informational materials have been produced based on the availability of data on all identified cancer cases in the U.S. Without this National dataset, public health evaluations and research studies would have to rely on patients in clinical trials or on hospital-based data. The fact that the NPCR data received by CDC are population-based and include National data means that all socio-economic groups are included. These kind of representative data are not produced by hospitals or clinical trials that are limited in the populations they serve. The results of studies from specialized populations or clinical trials can result in erroneous conclusions about cancer incidence and survival. Trends in disparities in the cancer burden, success or failure of screening programs, and improvements in treatment can only be studied in broad-based, population-based data, which are standardized and collected on an ongoing basis. In addition, incidence rates and trends for rare cancers and for special populations such as American Indian/Alaska Natives can only be calculated accurately with a National-level dataset, which is available for this purpose because of the NPCR data submission to CDC.

Specific examples of data use are provided below.

Cancer Surveillance: The CDC and the states face the challenge of reducing cancer morbidity and mortality through prevention and early detection. Effective cancer control requires the regular, ongoing collection and analysis of health-related data to monitor the frequency and distribution the disease in the population. The NPCR CSS helps CDC continue to meet its public health responsibilities by providing routine surveillance reports on the national cancer burden by demographic characteristics, tumor characteristics, survival time, and other items of interest to the public health agencies responsible for the design, implementation, and evaluation of cancer prevention and control activities. CDC’s prevention efforts are enhanced by the ability to target areas with high rates of cancer with appropriate screening such as mammography, Pap tests, and colorectal cancer screening. The Agency for Healthcare Research and Quality (AHRQ) includes measures for effectiveness of care in cancer (http://www.ahrq.gov/research/findings/nhqrdr/nhqrdr13/measurespec/breast-cancer.html).The AHRQ Healthcare Quality Report includes rates of advanced stage female breast and colorectal cancer and all invasive cervical cancer by state.

Since 2002, CDC and the NCI, have published the United States Cancer Statistics (USCS) (http://www.cdc.gov/cancer/uscs). The USCS report contains a set of official federal cancer incidence statistics from each state that had high quality registry data. For cancer cases diagnosed in 2018, the most recent year for which federal data is available, 49 statewide population-based cancer registries and the District of Columbia met USCS publication criteria resulting in 99% population coverage. Data for selected cancer sites are also available as pre-calculated counts and rates on the NCI/CDC State Cancer Profiles Website (http://statecancerprofiles.cancer.gov/) and on the CDC’s WONDER Website (http://wonder.cdc.gov/CancerIncidence.html).

The Council of State and Territorial Epidemiologists (CSTE) includes cancer as part of the chronic disease indicators of the National Public Health Surveillance System (NPHSS) (9). The NPCR CSS continues to work to make timely data available for the NPHSS and publication in the Morbidity and Mortality Weekly Report.

Program Planning and Evaluation: CDC sponsors and supports a wide variety of public health programs in the U.S. designed to monitor and reduce morbidity and mortality from cancer such as the National Comprehensive Cancer Control Program, National Tobacco Control Program, the National Breast and Cervical Cancer Early Detection Program, the National Colorectal Cancer Roundtable, prostate cancer control initiatives, and the National Skin Cancer Prevention Education Program. Increasingly, there is Congressional and public demand for federal agency documentation and accountability of achievement of program objectives and outcomes (e.g., the Government Performance and Results Act of 1993).

Cancer information collected under NPCR CSS is very important to evaluate the success and remaining challenges in meeting CDC program goals and objectives, as well as to identify areas that can benefit from education and training, technical assistance, and other resources.

A.3 Use of Improved Information Technology and Burden Reduction

All NPCR registries submit their data to CDC electronically in a standardized format established by NAACCR and used by all cancer registry systems in North America. Because the formats and definitions have been well established for many years, the electronic submission of de-identified data to CDC requires minimal effort by the NPCR CCR. Data submission is via a secure socket layer (SSL) encryption and each NPCR registry is provided a one month time period for completion of their data submission. Software and statistical programs are provided to create the data set for submission. This process includes removal of identifiers such as name, address, and Social Security Number (SSN).

A.4 Efforts to Identify Duplication and Use of Similar Information

Limited cancer incidence data are available through the NCI SEER Program, which currently represents 9%-47% of the population of the U.S. (http://seer.cancer.gov). Nineteen states currently receive joint funding from the two federal programs and report their data to both federal agencies. SEER data are of high quality and are used to analyze long term trends in cancer incidence, patient survival, and for many other research purposes. While the SEER data are appropriate for some analyses, these data are not representative of the U.S. population and are often not adequate for analysis of U.S. regions, racial/ethnic populations, and rare cancers. These data are also not useful for the 31 states without a SEER registry for program planning and evaluation. NPCR-funded registries cover 97% of the U.S. population and complement the SEER data to provide 100% coverage of the U.S. population. In the states where the SEER program covers a part of the state (Alaska and Arizona) and the state participates in the NPCR, there is no duplication of effort. The SEER program reports data from its catchment area to the NPCR-funded state central cancer registry.

NAACCR plays a leadership role in setting standards for the collection of cancer data and currently publishes population-based state cancer incidence data and aggregated state data yearly in Cancer Incidence in North America (CINA) (10). The submission of data to NAACCR is voluntary and varies from year to year. No public use data set is available to meet both public health surveillance needs and NPCR needs for program planning and evaluation.

The National Cancer Data Base (NCDB) from the American College of Surgeons (ACoS) (https//www.facs.org/quality-programs/cancer) contains data items required by the Commission on Cancer Approvals Program. NCDB is based on approximately 1,500 participating hospitals. The program was started in 1989 and approximately 70% of all U.S. cancer cases are collected annually. The data are not population-based since NCDB does not collect all cancer cases in a defined geographic area and cannot be used to calculate incidence rates. In addition, while the NCDB strives to reduce the number of multiple reports, the system cannot identify multiple cancer reports for the same individual that may arise from a surgical hospital, pathology laboratory, and treatment facilities. This means that a single case may be reported multiple times in the database.

While there are a number of cancer registration activities in the U.S., it is clear that the resulting data do not meet the public health need for a national cancer surveillance system. The NPCR CSS is unique in meeting the national need for a population-based dataset with adequate numbers of rare cancers, representation of racial/ethnic populations, and state-based data for program planning and evaluation.

A5. Impact on Small Businesses or Other Small Entities

Respondents are state-based central cancer registries. No small businesses will be involved in this information collection.

A6. Consequences of Collecting the Information Less Frequently

Because of the time needed to collect and aggregate data from a large number of cancer cases each year, NPCR registries report to CDC final data that is already two years old and typical data analyses from these data are three years behind the current diagnosis year. Delaying these data reports any further would jeopardize the ability of the national cancer system to reflect cancer trends of current importance. Instead, the emphasis has been to try and provide more recent data from surveillance systems.

It is important to provide annual information on the national cancer burden to CDC officials, Congress, constituents, and other Federal, State, and local agencies. The data are also used to evaluate the success over time of prevention (tobacco control) or screening (breast, colorectal, cervical) efforts at the state and National level.

In addition, CDC’s ability to monitor and improve program effectiveness will be compromised if data is collected less frequently. It is essential that CDC and State program managers evaluate program strengths and weaknesses on an annual basis and make adjustments. Because of staff changes or other issues, a central registry that has performed well in the past may yet have problems with data quality or completeness of case ascertainment. It is critical to identify these registries as soon as possible so that needed technical assistance or guidance can be provided.

During this period CDC will support two submissions per year. The additional preliminary submission in January will allow CDC to prepare to produce early estimates of cancer incidence and other statistics, in advance of the detailed data validation steps required for the November submission. Also, the assessment of data quality will allow for earlier technical assistance to central registries that are having difficulties. As electronic reporting continues to grow, this earlier submission provides a foundation for reporting final data earlier for public health purposes. Without this initial work to evaluate and improve the quality of this earlier data, progress cannot be made toward this goal.

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

A8. Comments in Response to the Federal Registrar Notice and Efforts to Consult Outside the Agency

A Notice was published in the Federal Register on November 22, 2021, Volume 86, No. 222, pp. 66308-66309 (Attachment 6). One non-substantive public comment was received (Attachment 6a).

Since NPCR’s inception, DCPC/NPCR staff have regular monthly conference calls, quarterly Town Hall webinars, and Program Review/Technical Assistance meetings with NPCR Central Cancer Registry staff to provide feedback and input into NPCR operations including data collection requirements and procedures. The monthly calls include a subset of Program Directors who participate on a rotating basis while the Town Hall webinars and Program Review/Technical Assistance meetings include all NPCR registries (Attachment 7).

In addition, CDC works closely with NCI SEER staff to share information about data collection requirements and methods to ensure consistent National data and to provide guidance to states that are co-funded in operational procedures. In addition to regular calls (during 2021 and ongoing) with NCI staff, CDC and NCI staff serve together on numerous committees and workgroups including NAACCR work groups where standards are set for data collection and reporting throughout North America. These workgroups are ongoing.

CDC also confers on an ongoing basis with other partners including the American Joint Committee on Cancer, which establishes staging criteria in the U.S., and the ACoS Commission on Cancer, which certifies hospitals in cancer care. These hospitals operate most of the hospital-based cancer registries.

A9. Explanation of Any Payment or Gifts to Respondents

No payment will be made to respondents (awardees) to submit NPCR data to CDC.

A10. Assurance of Confidentiality Provided to Respondents

This submission has been reviewed by Office of the Chief Information Security Officer (OCISO) at CDC which determined that the Privacy Act does apply. The Privacy Act applies because the system collects, maintains, uses, and shares information in identifiable form (IIF), specifically (1) names, e-mails, and user credentials of the cancer registry staff member responsible for the data submission and (2) medical notes, dates of birth, county and postal code of residence, census tract of residence, race/ethnicity, and sex of individuals diagnosed with cancer. The relevant Privacy Act System of Records Notice (SORN) that is being used to cover the system is 09-20-0160 Records of Subjects in Health Promotion and Education Studies. Data are submitted by state health organizations to CDC. CDC does not receive names, social security numbers (SSNs), or mailing addresses of individuals diagnosed with cancer.

Confidentiality and privacy are of paramount concern to CDC’s Division of Cancer Prevention and Control staff and contractors because of the confidentiality concerns of the awardees, the private nature of medical data in a cancer surveillance database, and the potential for direct and deductive identification of an individual in the NPCR CSS. After extensive discussions with the CDC Privacy Officer, CDC obtained an Assurance of Confidentiality (308(d)) on June 7, 2000, with multiple renewals, the most recent in 2020 (Attachment 4).

The risk of direct identification of an individual in NPCR CSS data is remote because names, SSNs, or mailing addresses are not reported to the CDC. However, a unique identifier for each individual diagnosed with cancer is assigned by the state and reported to CDC. CDC does not have access to the link between this identifier and the identity of the individual. The awardee maintains the linkage information between the unique codes and the personal identities in their database in order to respond to and follow-up on data queries from CDC. Since multiple primary cancers are a matter of research interest, the public use files must also contain a unique identifier for each individual so that individuals with multiple primary tumors can be assessed.

To address the issue of deductive identification of an individual because of small numbers (e.g., in a census tract), guidelines from the NCHS Staff Manual on Confidentiality are used (19). NCHS has guidelines for published data and one for micro-data files or public-use files. The guidelines for published data include: 1) In no table should all cases of any line or column be found in a single cell, 2) In no case should the total figure for a line or column of a cross-tabulation be less than five unweighted cases, and 3) In no case should a quantity figure be based upon fewer than five unweighted cases. The guidance for avoiding inadvertent disclosures through the release of micro data tapes includes: 1) “tape must not contain any detailed information about the subject that could facilitate identification and that is not essential for research purposes (e.g., exact date of the subject’s birth) and 2) Geographic places that have fewer than 100,000 people are not to be identified on the tape. These guidelines from NCHS serve as a model for NPCR CSS as confidentiality procedures. In addition, the program will need to be attentive to changes in the environment that may impact efforts to maintain confidentiality.

Additional information on privacy safeguards applicable to data collection, de-identification, coding, transmission, storage, and reporting appears below.

B. The NPCR CSS data are secured by technical, physical, and administrative safeguards. A data contractor has been retained to assist with data management and analysis. The safeguards are:

Technical

The NPCR CSS project has completed the required Security Certification and Accreditation renewal process managed by CDC’s Chief Information Security Officer.
CDC uses a contractor for the data submission process. The NPCR CSS project data reside on a dedicated server that resides on the contractor’s local area network (LAN) behind the contractor’s firewall and is password protected on its own security domain. Access to the NPCR CSS server is limited to the contractor’s authorized project staff. No other non-project staff are allowed access to the NPCR CSS. All staff must pass background checks appropriate to their responsibilities for holding a public trust position. All of the contractor’s project staff are required to sign a confidentiality agreement before passwords and keys are assigned.
NPCR CSS data that are submitted electronically are encrypted during transmission from the awardees. The data arrive on a document server behind the data collection contractor’s firewall. Each awardee has its own directory location so no awardee has access to another awardee’s data. The data are moved automatically from the document server to the NPCR CSS server.
Once the data have been compiled by the contractor and delivered to CDC via the document server behind the firewall, all NPCR CSS datasets are maintained for restricted access on CDC’s secure LAN server.

Physical

The contractor’s NPCR CSS server is housed in a secure, guarded facility. All contractor staff are issued identification badges. Elevator and stairwell access is controlled by key cards.
Receipt and processing logs are maintained to document data receipt, file processing, and report production. All reports and electronic storage media containing NPCR CSS data are stored under lock and key when not in use and will be destroyed when no longer needed.
Once the data is compiled by the data collection contractor and delivered to CDC, all NPCR CSS datasets are maintained for restricted access on a secure LAN server, which is housed in a secure facility. All CDC staff are issued identification badges and access to the building is controlled by key cards.

Administrative

CDC staff and the contract staff have developed a security plan to ensure that the data are kept secure and confidential. Periodic review and update of the data collection contractor’s security processes is conducted to adjust for rapid changes in computer technology and to incorporate advances in security approaches. The security plan will be amended as needed to maintain the continued security and confidentiality of NPCR CSS data.
All project staff receive annual security awareness training covering security procedures. The contractor’s project security team oversees operations to prevent unauthorized disclosure of the NPCR CSS data.

Once the data is delivered to CDC, access to these datasets is only granted when appropriate confidentiality release forms have been signed and returned to the NPCR CSS Data Security Steward.

A11. Institutional Review Board (IRB) and Justification for Sensitive Questions

Collection of incidence data for surveillance is considered public health surveillance rather than research. In discussions with the CDC Office of Science Privacy and Confidentiality Unit, in 2020, a determination was made that epidemiologic analysis of the NPCR data no longer requires IRB approval due to recent changes in the Common Rule. A request to close CDC IRB study protocol #2594 was submitted in January 2021. (Attachment 8).

A12. Estimation of Annualized Burden Hours and Costs

Respondents are the 50 NPCR central cancer registries (46 states, the District of Columbia, Puerto Rico, US Virgin Islands, and the Pacific Islands Jurisdiction). CDC is requesting two submissions per year. Each submission will include all NPCR registries reporting standard data items listed in Attachment 3a.

The estimated burden per response is 2 hours. All information is reported to CDC electronically. The total estimated annualized burden is 200 hours. States prepare their data files and send them electronically to CDC. The web page displays the OMB control number, the expiration date and a burden statement (Attachment 9). This information appears on the log in page of the website that the states use to transfer their files electronically.

Table A12-A. Estimated Annualized Burden Hours

Type of Respondents

Form Name

No. of Respondents

No. of Responses per Respondent

Average Burden per Response (in hours)

Total Burden

(in hours)

Central Cancer Registries in States, Territories, and the District of Columbia

Standard NPCR CSS Report

200

Total

200

B. The annualized cost to respondents reporting data to CDC is estimated to be $7,200. It is estimated that the following state cancer registry personnel will be required to help prepare and submit data electronically to CDC: data managers, information technology staff and program directors. However, it should be noted that the specific nature of the work in the central cancer registries does not correlate with the employment categories as outlined by the Department of Labor. The categories listed below are similar in job description to those in central cancer registries.

Table A12-B. Annualized Cost to Respondents

Type of Respondents	Form Name	No. of Respondents	Total Burden (in hours)	Average Hourly Wage	Total Cost
Central Cancer Registries in States, Territories, and the District of Columbia	Standard NPCR CSS Report	50	200	$36	$7,200
	Total				$7,200

*Based upon U.S. Bureau of Labor Statistics. Occupational Employment Statistics. May 2009 National Occupational Employment and Wage Estimates. Washington, DC: U.S. Bureau of Labor Statistics. Available at: http://www.bls.gov/oes/current/oes_nat.htm#00-0000 [accessed November 27, 2018.]

A13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

The computer hardware and software needed for an electronic data submission to CDC are readily available to awardees since they already utilize these resources to collect and distribute cancer incidence data for state purposes; hence no capital or maintenance costs are anticipated.

A14. Annualized Cost to the Federal Government

The average annual cost for the contractor for NPCR CSS data collection is $2,468,818 per year for a five-year total of $12,344,094. Additional annual costs include personnel costs of federal employees involved in oversight and analysis. The annual staff cost is estimated at $120,000 (1.0 epidemiologist FTE, 0.2 public health advisor FTE, and miscellaneous expenses include travel, etc.).

Table A14-A. Estimated Annualized Federal Government Cost Distribution

	Annualized Cost
CDC Personnel Subtotal	$120,000
Data Contractor Subtotal	$2,468,818
Total	$2,588,818

A15. Explanation for Program Changes or Adjustments

This Revision request includes an update of data definitions that reflect changes in national standards for cancer diagnosis, treatment, and coding (Attachment 3b). The estimated burden per response and annualized burden hours have not changed.

A16. Plans for Tabulations and Publication and Project Time Schedule

CDC is requesting that Preliminary data (referred to as 12 month data) be submitted in January. These data will consist of one year of data for the most recent year of available cancer data. These data will be evaluated for completeness and quality and reports will be provided back to each registry and to CDC. Additional technical assistance will be provided as needed. These data may also be used to provide early reports of cancer incidence.

CDC is requesting that NPCR registries report Final Data (24 month data) each year in November. These data include diagnoses for each year the registry has been funded by NPCR to report data (1995 forward in many cases). Corrections and additions are added each year by the central cancer registries. Consequently each year the process of data submission, data editing, data enhancement, and creation of public use datasets will be repeated (Table A16). The schedule each year will be similar to what is found here:

Table A16. Time Schedule for Preliminary and Final Data Reporting, Analysis and Publication

Tasks	Standard NPCR CSS Report
Preliminary data (12 month data) received from registries	January
Data reviewed for quality and completeness and reports provided to CDC and central registries	March
Final Data (24 month and older data) received from registries	November
Data processed and edited by CDC	January
Data analysis file created	February
Data Evaluation Reports and data edits returned to awardees	April
United States Cancer Statistics published	June
Public use datasets available for surveillance	June
Datasets at NCHS Research Data Center	August

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

There is no request for a date display exemption.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

References:

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2015 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2018. Available at: www.cdc.gov/uscs.
Howlader N, Noone AM, Krapcho M, Garshell J, Miller D, Altekruse SF, Kosary CL, Yu M, Ruhl J, Tatalovich Z,Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/data/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018.

Havener L and Thornton M (editors). Standards for Cancer Registries, Vol II: Data Standards and Data Dictionary, 13^th ed. Springfield, Ill: North American Association of Central for Cancer Registries; 2008.
Haynes MA, Smedley BD. The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved. Washington (DC): The National Academies Press; 1999.
North American Association of Central Cancer Registries (NAACCR). Standards for Cancer Registries: vol. III: Standards for Completeness, Quality, Analysis and Management of Data. Springfield (IL): NAACCR; 2008.
Doyle P, Lane JI, Theeuwes JM, Zayatz LM (eds). Confidentiality, Disclosure, and Data Access: Theory and Practical Application for Statistical Agencies. Amsterdam: Elsevier Science BV; 2001.
McLaughlin C. Confidentiality protection in publicly released central cancer registry data. Journal of Registry Management 2002; 29(3):84-88.
National Center for Health Statistics. NCHS Staff Manual on Confidentiality. Hyattsville, MD: Centers for Disease Control and Prevention, National Center for Health Statistics; 1997.
Chronic Disease Committee, Council of State and Territorial Epidemiologists. Inclusion of Cancer Incidence and Mortality Indicators in the National Public Health Surveillance System (Position Statement #CD 4). June 1998.
North American Association of Central Cancer Registries. Cancer in North America, 2011-2015: volumes 1-3. Springfield (IL): North American Association of Central Cancer Registries; 2018. http://www.naaccr.org/DataandPublications/CINAPubs.aspx
Thornton ML, (ed). Standards for Cancer Registries Volume II: Data Standards and Data Dictionary, Record Layout Version 16, 20^th ed. Springfield, Ill.: North American Association of Central Cancer Registries, September 2015, revised October 2015, revised November 2015. http://datadictionary.naaccr.org/

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