Supporting Statement
Foreign Quarantine; Import Regulations for Infectious Biological Agents,
Infectious Substances, and Vectors (42 CFR 71.54)
(OMB Control No. 0920-0199)
Extension
Centers for Disease Control and Prevention
Office of Public Health Preparedness and Response
Division of Select Agents and Toxins
Lori Bane
(404) 718-2006
(404) 718-2097 FAX
August 18, 2016
Table of Content
1. Circumstances Making the Collection of Information Necessary 3
2. Purpose and Use of Information Collection 4
3. Use of Improved Technology and Burden Reduction 4
4. Efforts to Identify Duplication and Use of Similar Information 4
5. Impact on Small Businesses or Other Small Entities 5
6. Consequences of Collecting the Information Less Frequently 5
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 5
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5
9. Explanation of Any Payment or Gift to Respondents 5
10. Protection of the Privacy and Confidentiality of Information Provided by Respondents………………………………………………………………………………….5 11. Institutional Review Board (IRB) and Justification for Sensitive Questions……………7 12. Estimates of Annualized Burden Hours and Costs 8
13. Estimates of Other Total Annual Cost Burden to Respondents or Record keepers 9
14. Annualized Cost to the Government 9
15. Explanation for Program Changes or Adjustments 9
16. Plans for Tabulation and Publication and Project Time Schedule …………………….10
17. Reason(s) Display of OMB Expiration Date is Inappropriate…………………………10
Supporting Statement A
The goal of the study is to support Section 361 of the Public
Health Service (PHS) Act (42 U.S.C. 264) and prevents the
introduction, transmission, or spread of communicable diseases from
foreign countries into the States or possessions, or from one State
or possession into any other State or possession.
The intended use of the resulting data is to fulfill the
requirements promulgated by Health and Human Services under 42 CFR
71.54.
The methods used to collect data/information is an electronic data
collection system that uses electronic forms, which are available
on the Centers for Disease Control and Prevention’s Import
Permit website at http://www.cdc.gov/od/eaipp/ in a pdf-fillable
format for electronic submission.
The subpopulation to be studied are those academic institutions and
biomedical centers, commercial manufacturing facilities, federal,
state, and local laboratories, including clinical and diagnostic
laboratories, research facilities, exhibition facilities, and
educational facilities to request a permit
for the importation, and any subsequent distribution after
importation, of biological agents, infectious
substances, or vectors of human disease.
This collection of information does not employ statistical methods.
The data collection is mandated by 42 CFR 71.54.
This is a request for extension to OMB Control No. 0920-0199: Foreign Quarantine; Import Regulations for Infectious Biological Agents. The data collection and reporting requirements are required under 42 CFR 71.54 (Attachment 1). The Centers for Disease Control and Prevention (CDC) is requesting a 3-year approval for this data collection.
Section 361 of the Public Health Service Act (42 U.S.C. 264), as amended, authorizes that the Secretary of Health and Human Services (HHS) make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Part 71 of Title 42, Code of Federal Regulations (Foreign Quarantine) sets forth provisions to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the United States. Subpart F – Importations - contains provisions for the importation of infectious biological agents, infectious substances, and vectors (42 CFR 71.54); requiring persons that import these materials to obtain a permit issued by the CDC. The Centers for Disease Control and Prevention’s Import Permit Program (IPP) regulates the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States. Prior to issuing an import permit, IPP reviews all applications to ensure that entities have appropriate safety measures in place for working safely with these imported materials.
This information will assist with meeting the goals of the Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) and prevents the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.
The Permit to Import Biological Agents and Vectors of Human Disease into the United States is used by laboratory facilities, such as those operated by academic institutions and biomedical centers; commercial manufacturing facilities; federal, state, and local laboratories, including clinical and diagnostic laboratories; research facilities; exhibition facilities and educational facilities to request a permit for the importation, and any subsequent distribution after importation, of biological agents, infectious substances, or vectors of human disease. This form currently requests applicant and sender contact information; description of material for importation; facility isolation and containment information; personnel qualifications; where the imported material will be stored at the recipient facility and who would be responsible for this location; verification that the permittee has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use; and a secondary contact information for the permittee to provide in case the permittee is unavailable.
The Application for Permit to Import or Transfer Live Bats is used by laboratory facilities such as those operated by government agencies; universities; research institutions; and for educational, exhibition or scientific purposes to request a permit for the importation, and any subsequent distribution after importation of live bats. This form currently requests the applicant and sender contact information; a description and intended use of bats to be imported and facility isolation and containment information: and secondary contact information for the permittee to provide in case the permittee is unavailable.
The electronic forms are available at the CDC’s Import Permit website (http://www.cdc.gov/od/eaipp/importApplication) in pdf and pdf-fillable formats. Applications may be emailed, mailed or sent by fax. Using the pdf-fillable form, the applicant has the ability to save the document to the applicant’s local drive, complete the form, and then mail or fax the application to CDC. The use of electronic forms will facilitate a reduction in burden for those applicants submitting more than one form to CDC.
42 CFR 71.54 specifies that the importation permit is granted by CDC. No other component of HHS is involved in these procedures. The only way to obtain the necessary information is from the applicant.
Collection of information may involve some small businesses or other small entities, but the burden has been limited to providing minimal information on forms, verifying information by telephone, and mailing information to the appropriate parties. CDC has made every effort to ensure that the information collection is the minimal amount necessary to meet the requirements of the law and places a minimal burden on all parties involved.
There are legal obstacles to reducing the burden by collecting this information less frequently. The purpose of this information collection is to meet mandated regulatory requirements. If this information were collected less frequently, it would not be possible for CDC to carry out its commitments to protect the public health as mandated by these regulations.
This request fully complies with the regulation in 5 CFR 1320.5.
A. A 60 Day Federal Register Notice was published in the Federal Register on April 26, 2016, Vol. 81, No.80, Pages 24616-24618 (Attachment 2). There were no public comments.
There has been no consultation outside the agency due to the delegation of responsibilities to the CDC as described herein.
Respondents will not receive any payment or gift.
The following special safeguards are provided to protect the records from inadvertent disclosure:
Procedural Safeguards: Protection for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system; mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily backup procedures and secure off-site storage is available for backup files.
Knowledge of individual tape passwords is required to access tapes, and access to the system is limited to users obtaining prior supervisory approval. To avoid inadvertent data disclosure, a special additional procedure is performed to ensure that all Privacy Act data are removed from computer tapes and/or other magnetic media. A backup copy of data is stored at an offsite location and a log kept of all changes to each file and all persons reviewing the file. Additional safeguards may also be built into the program by the system analyst as warranted by the sensitivity of the data set.
The DSAT and contractor employees who maintain records are instructed in specific procedures to protect the security of records, and are to check with the system manager prior to making disclosure of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel.
Appropriate Privacy Act provisions are included in contracts and the CDC Project Director, contract officers, and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract.
Implementation Guidelines: The safeguards outlined above are in accordance with the HHS Information Security Program Policy and FIPS Pub 200, `Minimum Security Requirements for Federal Information and Information Systems. Data maintained on CDC's Mainframe and the OPHPR Local Area Network (LAN) are in compliance with OMB Circular A-130, Appendix III.
Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications.
The CDC will follow its established policies and procedures in releasing and/or withholding trade secret and/or confidential or financial information, in accordance with the Freedom of Information Act.
Privacy Impact Assessment Information
The following information is collected from the applicant to receive an import permit as required under 42 CFR 71.54. The information being collected to receive a permit as required under 42 CFR 71.54 includes the applicant’s name, mailing address, phone numbers, and email address. The information available on the permit includes the applicant’s name, mailing address, phone numbers, and email address.
The information is kept in a database which consists of permitted entities importing or subsequently transferring biological agents, infectious substances and vectors of human disease. This database is safeguarded; paper records are kept in locked files. Electronic data files are password protected and stored in a restricted access location. Only a small number of staff within DSAT has access to the information, and disclosure of information is stringently limited.
To comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, the attached draft Federal Register notice is in the clearance process for the System of Record Notice entitled, Etiological Agent Import Permit Program (EAIPP) 2.0, HHS/CDC/OPHPR (Attachment 4).
Institutional Review Board approval is not required. These activities were determined to be public health non-research. (Attachment 6)
This data collection does not include personal questions of a sensitive nature.
We estimate based on information obtained from the CDC import permit database on the number of permits issued on annual basis since 2010 that there will be approximately 1,625 respondents for permit requests per year and that the average response time to complete this questionnaire is 20 minutes. The total estimated burden for the one-time data collection is 545 hours. There are no costs to respondents except their time.
Type of Respondent |
Form Name |
No. of Respondents |
No. Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden Hours |
Applicants Requesting to Import Biological Agents, Infectious Substances and Vectors |
Application for Permit to Import Infectious Biological Agents into the United States |
1625 |
1 |
20/60 |
542 |
Applicants Requesting to Import Live Bats |
Application for Permit to Import or Transport Live Bats |
10 |
1 |
20/60 |
3 |
Total |
|
|
|
|
545 |
Type of Respondent |
No. of Respondents |
No. Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden Hours |
Hourly Wage Rates |
Total Respondent Costs |
Applicants |
1625 |
1 |
20/60 |
542 |
28.87 |
$15,647.54 |
Applicants |
10 |
1 |
20/60 |
3 |
28.87 |
$86.61 |
Total |
|
|
|
545 |
|
$15,734.15 |
To estimate costs to respondents, CDC assumed that the hourly burden rate would be evenly split between managerial staff and clerical staff. CDC assumed an average hourly respondent labor rate (including fringe and overhead) of $41.86 for managerial staff (e.g., researchers) and $15.88 for clerical staff (e.g., graduate students/assistants). To calculate the mean hourly rate, we averaged these two figures for an hourly wage rate of $28.87. These rates were obtained from the Bureau of Labor Statistics, from the 2012 Occupational Employment Statistics Survey by Occupation (http://www.bls.gov/oes/).
Respondents incur no capital or maintenance costs. The only costs incurred to respondents are those associated with telephone calls, mailing, and fax transmissions. All of these costs are part of normal business expenses.
The total estimated cost for implementing these regulatory activities for fiscal year 2016 is $1,335,495. This estimate includes 6 full-time Federal Employees (FTE) currently working in the import permit program. It also accounts for the program performing 23 inspections per year with two inspectors at a cost of $2000 per inspection. Additional costs incurred by the program are costs as shown below.
FY 2016 Annualized Government Cost
Personnel: 6 FTEs $ 504,607
Travel: $ 92,000
Import Permit Database: $ 697,840 Equipment, supplies and materials: $ 37,063 Administrative Costs: $ 3,985
Total: $ 1,335,495
This is a Request for Extension of a currently approved collection. There has been no change in burden from the current inventory.
There are no plans for tabulation and publication of this data. The data collection is used solely to carry out the provisions of the regulation.
The display of the OMB expiration date is not inappropriate.
There are no exceptions to the certification.
Attachment 1 Foreign Quarantine; Import Regulations for Infectious Biological Agents,
Infectious Substances, and Vectors (42 CFR 71.54)
Attachment 2 60-Day Federal Register Notice
Attachment 3 Public Comments to 60-Day Federal Register Notice
Attachment 4 System of Record Notice
Attachment 5a Application for Permit to Import Infectious Biological Agents (Infectious Substance and Vectors) of Human Disease into the United States
Attachment 5b Application for Permit to Import or Transfer Live Bats
Attachment 6 Determination of Applicability for Human Subjects
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | zoz1 |
| Last Modified By | Zirger, Jeffrey (CDC/OD/OADS) |
| File Modified | 2016-08-18 |
| File Created | 2016-08-18 |