IACUC Supporting_Statement_A 7-17-2019

Supporting Statement A

National Park Service Institutional Animal Care and Use Committee (NPS IACUC)

Amendment, Annual Review, Field Study, Concurrence, and General Submission Forms

OMB Control Number 1024--0265

Terms of Clearance: None.

General Instructions

A completed Supporting Statement A must accompany each request for approval of a collection of information. The Supporting Statement must be prepared in the format described below, and must contain the information specified below. If an item is not applicable, provide a brief explanation. When the question “Does this ICR contain surveys, censuses, or employ statistical methods?” is checked "Yes," then a Supporting Statement B must be completed. OMB reserves the right to require the submission of additional information with respect to any request for approval.

Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.

The National Park Service (NPS) is requesting a renewal of this collection. Pursuant to the Animal Welfare Act (AWA), Animal Welfare Act Regulations (AWAR), and the Interagency Research Animal Committee (IRAC), any entity or institution that uses vertebrate animals for research, teaching, or training purposes must have an oversight committee to evaluate all aspects of that institution's animal care and use. To be in compliance, the NPS is responsible for managing and maintaining an Institutional Animal Care and Use Committee (IACUC) that provides the experience and expertise necessary to assess and approve all research, teaching, and training activities involving vertebrate animals on NPS managed lands and territories.

All research, teaching, and training projects involving the use and care of vertebrate animals taking place on NPS territories must be reviewed and approved by the NPS IACUC prior to starting. Principal Investigators (PI) are required to submit one of the following forms for consideration by the committee:

• The NPS IACUC General Submission (GS) form

• The NPS IACUC Field Study form

• The NPS IACUC Concurrence Review form

• The NPS IACUC Amendment form

• The NPS IACUC Annual Review form

As determined by the AWA, the NPS IACUC is a self-regulating entity that currently consists of a Chair, a veterinarian to serve as the “Attending Veterinarian,” and another individual to serve as the “Unaffiliated Member At-Large”.

Relevant Legislation:

• Animal Welfare Act, 7 U.S.C. 2131-2159;§2.31, d, 1

“the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing…”

• NPS Organic Act, 16 U.S.C. §a-1

“…which purpose is to conserve the scenery and the natural and historic objects and the wild life therein and to provide for the enjoyment of the same in such manner and by such means as will leave them unimpaired for the enjoyment of future generations”.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection. Be specific. If this collection is a form or a questionnaire, every question needs to be justified.

The NPS IACUC will continue to use this information to ensure that sufficient and relevant information is available to evaluate proposed research projects, teaching, or training activities involving the use of animals within NPS units. Each animal project must be reviewed by the NPS IACUC committee annually. Review of a new General Submission or Concurrence form is required every three years, or less frequently for ongoing activities. The review process covers the following points:

• Identification of the species and approximate number of animals to be used.

• Rationale for involving animals, the appropriateness of the species, and numbers used.

• A complete description of the proposed use of the animals.

• A description of procedures designed to assure that pain and distress experienced by animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs, or other effective methods, will be used where indicated and appropriate to minimize distress and pain to animals.

• Description and support of any euthanasia method to be used.

In review, the IACUC is required to ensure that the proposed work is consistent with the treatment of animals as described in the AWA, and that the following points are covered:

• Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.

• Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.

• Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

• The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.

• Medical care for animals will be available and provided as necessary by a qualified veterinarian.

• Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.

• Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.

1. The General Submission form: This form has not been changed from the 2016 version except to add clarifying language and to make the input of information more user friendly. This form requires the following information:

• A project narrative which includes: the title, a statement of the objectives to be addressed, scope of the proposed project, literature review for alternatives to potentially painful or distressful procedures, and description of the methods and procedures to be used.

• A description of the qualifications of the principal investigators, all personnel involved, and delegated attending veterinarians on the project.

• Details and descriptions of animals used in the project.

• A search for alternatives to procedures that may cause more than momentary or slight pain and distress to the animals

• Sections involving surgical procedures are hidden unless the researcher is planning to conduct surgical activities, thereby reducing the burden of completion by the researcher and of time for review by the IACUC members

• A list of the permits necessary to conduct the project.

• A signed declaration of compliance with the procedures and methods outlined in the AWA, its Regulations, and the IRAC.

General Submission Form
Previous Version	Updated Version
Page 1:“Check List”	MOVED check list to Pg. 2, after important protocol information that is unique to each submission; check list does not change
n/a	Page 1: ADDED “date of submission” to track how long it takes for the IACUC to review and approve protocols
Page 2: NPS Contact (name, unit, email, phone number), possible 3 entries	Page 1: CHANGED from 3 to 2 possible entries, because 2 is the most common response
Page 2: “Funding Sources” acronym and spell-out acronym	REMOVED acronym box, because it was rarely used
n/a	Page 1: ADDED “to see an example for a field, hover over the [yellow question box] buttons throughout the form” to inform PIs that those buttons contain information related to completing form
Page 2: “Is this an ongoing project?”	MOVED to Page 1: ADDED yellow question box to this question to elaborate on the meaning/context
n/a	Page 2: ADDED “Does this project include any TEACHING or TRAINING of students and/or staff?” to track projects that involve teaching or training and have assurance that trainees/students will be properly trained and supervised to ensure safety of animals and personnel
Page 6: Tables “Opportunistic Animals” and “Non-Target Animals”	Page 5: COMBINED opportunistic animals and non-target animals into one table to streamline collection of information and save space. Reformatted table to match style of “study animals” table.
Page 8: Yellow question box “Do any proposed procedures cause more than momentary or slight pain or distress” yellow question box and “Search Strategy”.	Page 6: REMOVED yellow question box from “Do any proposed procedures cause…” and incorporated that information in the body of the form Page 7: “Alternatives to Painful Procedures Search” and “Search Strategy” now includes links to resources for PI
Page 10: Question 1 - “Is this a behavioral or observational study (without prolonged restraint or noxious stimuli)” and Question 2- “Is this a behavioral or observational study (with prolonged restraint or noxious stimuli)”	Page 9: COMBINED both questions: “Will there be behavioral or observational testing?” to streamline the collection of information and to save space
Page 12: Euthanasia and Disposition	Page 11: ADDED link to guidelines for euthanasia of animals as resource for the PI
Page 12: euthanasia and disposition yellow question box	Page 11: REMOVED yellow question box and moved text into body of form “Even if you do not intend to euthanize animals...” to ensure it is seen by all PIs as this is very important information for animal welfare compliance
Page 12: Question 1 - “Describe method of euthanasia planned” and Question 2“Describe method used to ensure the animal will not revive.	Page 11: COMBINED questions “Describe the PRIMARY method of euthanasia as well as a SECONDARY method to ensure the animal will not revive. Include personnel...” to streamline collection of information.

2. The Concurrence and Field Study forms: These are used for projects that will not require the same level of review or information as the General Submission form and will reduce the time for completion by a total of 235 hours. These forms will require the following information:

• A project narrative which includes: the title, a statement of the objectives to be addressed, scope of the proposed project, and description of the methods and procedures to be used.

• A description of the qualifications of the principal investigators, all personnel involved, and delegated attending veterinarians on the project.

• Details and descriptions of animals used in the project, if not provided in an approved protocol from an IACUC outside of NPS or in a form from another oversight agency.

• A signed declaration of compliance with the procedures and methods outlined in the AWA, its Regulations, and the IRAC.

Concurrence Form
Previous Version	Updated Version
Page 1: Question 1 - submitter’s name, email, and phone number	REMOVED submitter information because the Principle investigator is often the submitter and it was redundant; REPLACED with NPS contact info (name, unit, email, phone number) to ensure PI has talked with someone at park
Page 1: Question 1 - project approval period	REMOVED project approval period question because it was deemed to be redundant and confusing, information still captured in question 2 (expiration date)
Field Study Form
Previous Version	Updated Version
n/a	Page 1 - NEW ADDED “NPS unit(s) associated with this submission” to explicitly ask PI which NPS parks they are working in
n/a	Page 1 - NEW ADDED NPS contact info (name, unit, email, phone number) to ensure PI has talked with someone at park
n/a	Page 1 - NEW ADDED “How would you explain to a non-scientist, the specific objective(s) of your study?” to stay consistent with information gathered in General Submission Form
Page 2: Question - “Are any additional procedures to be done as part of the demonstration?”	REMOVED vague question and replaced with specific questions to stay consistent with information gathered in General Submission Form.: “ What PPE will be used? What cleaning procedures of equipment will be done?” Also included links to online resources for safety and biosecurity.
Page 2: Question - “Who will be involved? Please list their experience and qualifications.”	UPDATED language to be more explicit in the details needed to conduct the review and to stay consistent with information gathered in General Submission Form. “Who will be involved in handling animals? For staff, please provide first and last name, relevant education, training, and species/procedures experience. For trainees or students please provide type of training and supervision for procedures”
n/a	Page 1 - NEW ADDED question about euthanasia in the field in case of emergency.

3. The Amendment and Annual Review forms: Both of these forms will require the following information:

• Identifying any changes to the approved IACUC submissions including additions or deletions of personnel, species or numbers to be used, procedural changes or refinements.

• A signed declaration of compliance with the procedures and methods outlined in the AWA, its Regulations, and the IRAC.

Amendment Form
Previous Version	Updated Version
n/a	Pg. 1: NEW ADDED “NPS IACUC Project Name”
n/a	Pg. 1: NEW ADDED “original approval date” and “is this an ongoing project” to track length of projects.
Pg. 1: “Will new procedures be performed?” “Are changes to approved procedures planned?” pg 2: “Are changes planned to anesthesia drugs for the approved procedures?”	Pg 1: COMBINED these 3 questions. “Are changes to approved procedures or anesthesia drugs planned? Will new procedures be performed?” For any affirmative responses, text boxes will appear requesting specific information related to the response
pg. 2: “Will euthanasia method be changed”	Pg. 2: NEW ADDED link to guidelines for euthanasia of animals for PI’s reference
Pg. 2: “Will any other changes not listed above be made to the approved project?”	Pg. 2: REPLACED with “Do you have new or additional personnel you need to add to your protocol?” Personnel changes is the most common response to the previous version of the question..
Pg 3: Alternative Search ( yellow question boxes)	Pg. 3: REMOVED yellow question boxes. ADDED the text into the form body to make information available on printed versions of the form.
Annual Review Form
Previous Version	Updated Version
n/a	Pg. 1: NEW ADDED “Date of Submission” to track timeliness of submissions
n/a	Pg. 1: NEW ADDED “NPS IACUC Project Name”
Pg 1: Principal Investigator	Pg. 1: NEW ADDED contact information (email and phone number)
Pg. 1: “Deadline for Submission”	Pg 1: REPLACED with “Original Approval Date” to track project status
Pg 1: “Will your project remain active until the next IACUC approval anniversary”	Pg 1: REPLACED with “What is the expected end date of your project?” Needed to track projects that extend beyond the 3-year approval period.
Pg 1: “Anniversary Date”	Pg 1: REMOVED because it was confusing (same date as original approval)
Pg. 3: “The Principal Investigator for this project has changed”	Pg. 1: MOVE to first page
Pg. 1: “Your assurance of animal care is due…”	REMOVED text because it is no longer accurate.
Pg. 1: “Provide a summary of your activities…”	Pg. 1: MOVED text from text box into form body, because the text box was often ignored by PIs
Pg. 1: “Have any changes to the IACUC approved project been made in the last year?”	Pg. 1: REPLACED with “Are changes to the IACUC approved protocols planned in the next year?” Any changes must be approved by the IACUC before implementation.
Pg. 3: “Have any NPS Contacts changed?” 3 possible entries	Pg. 2: REDUCED number of possible entries from 3 to 1. This is the most common response and it saves space on the form
Pg. 2: Table “Study, Opportunistic, and Non-Target Animal Numbers Used During Year Under Review”	Pg. 2: REDUCED the number of rows in table, because number of species used is rarely greater than 10.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden and specifically how this collection meets GPEA requirements

All forms are submitted to IACUC using an electronic fillable pdf format. Respondents submit all forms electronically using the NPS IACUC email at [email protected]. Information related to the forms is on the program’s website: https://www.nps.gov/orgs/1103/iacuc.htm.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

The NPS IACUC is solely responsible for collecting and reviewing this information for projects involving the use of vertebrate animals in NPS units. The information that we collect is not available from any other source. The Concurrence forms (A2), require the researchers to submit a copy of an approved form from their primary institution outside of the NPS as a way to minimize duplication.

5. If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.

The collection of this data will not have any significant impacts on small businesses. The completion of any form is considered as part of normal business activities to conduct research

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden

If we do not collect this information, the NPS would be in violation of the AWA and its Regulations. Specifically, the NPS would not have the information necessary to comply with their annual requirements to prepare a report for the USDA concerning the number and use of animals in the following categories:

1. those being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.

2. those upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs.

3. those upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs, or other effective relief methods were used.

4. those upon which teaching experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

* requiring respondents to report information to the agency more often than quarterly;

* requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

* requiring respondents to submit more than an original and two copies of any document;

* requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

* in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study;

* requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

* that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

* requiring respondents to submit proprietary trade secrets, or other confidential information, unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no circumstances that require the information to be collected in a manner inconsistent with OMB guidelines.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice [and in response to the PRA statement associated with the collection over the past three years] and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported. [Please list the names, titles, addresses, and phone numbers of persons contacted.]

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years — even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

On May 14, 2019, a 60-day Federal Register notice (84 FR 21355) was published announcing this information collection. Public comments were solicited for 60 days ending July 13, 2019. No comments were received.

In addition to publishing the 60 day Federal Register notice, we actively solicited peer reviews from sister agency IACUC representatives, researchers who may need to submit the forms for review, and IACUC members and consultants who might review these forms. We asked them to provide feedback about the clarity of instruction and the estimated time to complete the updated versions of the forms. Based on their previous experiences with the IACUC process, the individuals listed below provided suggestions and feedback concerning the, structure, clarity of the procedure and approximate length of time it would take to complete the forms. The reviewers said that the website’s instructions were easy to follow, and that the forms were very straightforward. We did not change the content of the forms or the website, because the reviewers suggested that no changes or updates were necessary at this time. The respondents concurred with our estimated burden time needed would be 3 hours to complete the General Submission form; 1 hour to complete the Field Study form; 15 minutes to complete the Concurrence form; 30 minutes to complete the Amendment form; and 15 minutes to complete the Annual Review form. These estimates reflect the time it will take each applicant to prepare the narrative and provide the additional background information needed to complete the application.

Reviewer# 1 Northeast Regional Biologist (NPS IACUC member)

National Park Service

817-270-7537

Reviewer# 2 Integrated Pest Management Technician

National Park Service

307-739-3644

Reviewer #3 Animal Care Program Manager (NPS IACUC non-affiliated member)

San Jose State University

408-924-4929

Reviewer #4 Wildlife Veterinarian

United States Fish and Wildlife Service

571-216-5776

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

We do not provide payment or gifts to respondents in this collection.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

NPS provides no promise of confidentiality. Name and contact information of the applicant are requested, but are only used for official business information, not private information. Despite this distinction, because information in the can be retrieved by name of the applicant. When a person visits this web site and submits the forms, that information will be stored in a secure database. We retain this information in order to provide feedback and a response from the committee concerning their request. This information is not used to associate patterns of site navigation with individual users. We will never use individual profiles for commercial marketing or any purposes other than for the submission of these forms.

The following information will be stored:

• names, phone numbers, and emails for the researcher and any other personnel involved in the projects;

• name, registration and permit numbers, protocol numbers, and contact information for other Institutional Animal Care and Use Committees associated with the project;

• audiovisual recordings submitted in conjunction with forms for project activities;

• confidential or proprietary information regarding the data collected and plans for use in future ventures.

Personal information collected on these forms is protected under the Privacy Act of 1974. The Privacy Act System of Records Notice associated with this information collection will be Research and Animal Care Forms (NPS-25). We will submit a copy of the final SORN as Non-substantive Change Request as soon as it is published in the Federal Register.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

The collection does not include questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information. The statement should:

* Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

* If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

* Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here.

Based on our administrative experiences plus the outreach described in item 8, we expect to receive 230 annual responses. The annualized respondent burden for this collection is estimated to be 135 hours. The frequency of response will be on occasion or as needed. Listed is average completion time for each form below:

• General Submission form - 3 hours ;

• Field Study form - 1 hour

• Concurrence Form - 15 minutes

• Amendment form - 15 minutes

• Annual Review form - 15 minutes.

Because of the differences in user familiarity and the amount of information provided in each form, as well as the time it takes for individual computer systems to make the connection with our website we expect slight variations in the time to complete each form. The data entry level sought is the same as used in most computer operating programs (no advanced knowledge, training, or expertise is required). For the respondents reporting more than one species per report the additional time is calculated in the average time to complete the form.

Table 12.1. Estimated Annual Burden Hours

Respondent and forms	Annual Number of responses	Completion Time Per form	Total Burden (hours)*
State and Local Agencies
General Submission Form	14	3 hours	42
Amendment Form	10	15 mins	3
Annual Review Form	55	15 mins	14
Field Study Form	10	1 hour	10
Concurrence Form	41	15 mins.	10
Subtotal	130		79
Private (non-profit)
General Submission Form	10	3 hours	30
Amendment Form	10	15 mins	3
Annual Review Form	40	15 mins	10
Field Study Form	10	1 hour	10
Concurrence Form	30	15 mins	8
Subtotal	100		61
TOTAL	230		140

* The calculations in this table are rounded up to the nearest whole number.

We estimate the total dollar value of the annual burden hours to be $$6,124 (Table 2). The estimated dollar value of the burden hours for this collection takes into account the nature of our respondents state and local government agencies and private businesses, (this includes university and non-profit employees). This estimated dollar value included the multiplier for benefits based on the National Compensation Survey: Occupational Wages in the United States published by the Bureau of Labor Statistics Occupation and Wages, (BLS news release USDL-19-1002 for Employer Costs for Employee Compensation—March 2019 at https://www.bls.gov/news.release/ecec.nr0.htm (Released June 18, 2019). The particular values utilized are:

States and Local Agencies: Average hourly wage is $50.89. To obtain the rate for State and local government, we used data from https://www.bls.gov/news.release/pdf/ecec.pdf- Table 3.

Private Businesses (e.g., non-profit and Private Universities): Average hourly wage is $34.49. To obtain the rate for professionals in the private sector we used data from https://www.bls.gov/news.release/pdf/ecec.pdf -Table 4.

Table 2. Estimated Dollar Value of Annual Burden Hours

Sector	Total Annual Number of Responses	Total Annual Burden Hours	Dollar Value of Burden Hours (Including Benefits)	Total Dollar Value of Annual Burden Hours
State and Local Agencies	130	79	$50.89	$4,020
Private Businesses (non-profit and Private Univ.)	100	61	$34.49	$2,104
TOTAL	230	140		$6,124

13. Provide an estimate of the total annual non-hour cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected in item 12.)

* The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information (including filing fees paid for form processing). Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

* If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

* Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

There is no non-hour cost burden to applicants resulting from this collection. There are no fees associated with this process or requirements.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information.

The total annual cost to the Federal Government is $244,160. This includes the cost to the Federal Government for salaries and benefits for administering this information collection ($241,660) and operational expenses ($2,500). Table 3 below shows Federal staff and grade levels associated with this information collection. We used the Office of Personnel Management Salary Table 2019-DEN (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/19Tables/html/DEN_h.aspx) to determine the hourly rate. We multiplied the hourly rate by 1.5 to account for benefits (as implied by the BLS news release USDL-19-1002 mentioned above). Operational expenses listed in Table 4 below.

Table 3: Annual Cost to the Federal Government

Position	Grade/ Step	Hourly Rate	Hourly Rate incl. benefits (1.5 x hourly pay rate)	Estimated time (hours)	Cost per federal staff (Hourly Pay Rate incl. Benefits)
IACUC Administrator	GS 7/5	$24.94	$37.41	1,664	$62,250
NPS Veterinarian	GS 12/5	$44.23	$66.35	1,664	$110,406
IACUC Committee Member	GS 12/5	$44.23	$66.35	520	$34,502
IACUC Committee Member	GS 12/5	$44.23	$66.35	520	$34,502
Total					$241,660

Table 4: Operational Expenses

Operational Expenses	Estimated Cost
Contract Support website oversight, database management, and maintenance	$2,500

15. Explain the reasons for any program changes or adjustments.

This is a renewal of a currently approved collection.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

The information collected will not be tabulated or published for statistical use. The forms will be stored in a database to maintain documentation of approved proposals.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

We will display the OMB control number and expiration date on all information collection instruments and the website.

18. Explain each exception to the topics of the certification statement identified in "Certification for Paperwork Reduction Act Submissions."

There are no exceptions to the certification statement.

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