Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Center for Drug Evaluation and Research, OCOMM

Funding Opportunity Title

CDER Strategic Communication Outreach (U18)

Activity Code

U18 Research Demonstration Cooperative Agreements

Announcement Type


Related Notices


Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity


Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)


Funding Opportunity Purpose

Reaching out to inform the American people is part of the mission of FDA’s Center for Drug Evaluation and Research (CDER) to promote and protect the public health. Communication about the risk and benefits, safety and effectiveness of human drug products to the public can be complex and challenging. As such, CDER’s Office of Communications (OCOMM) wants to leverage its communication efforts and collaborate with public outreach groups about its key initiatives and issues.

To effectively communicate with the public, CDER often tailors its messages to targeted segments of the population, i.e., elderly, children, healthcare professionals and young adults. Utilizing multiple approaches to convey information to the public may include multi-pronged educational campaigns, social media, the website, and working with various stakeholder groups.

CDER/OCOMM is soliciting proposals on a competitive basis for innovative projects that will foster better understanding of the work of CDER and the impact of that work on public health. CDER seeks to work with a non-profit educational public health outreach group with a commitment to educate and inform the American people about their medicines and the steps they can take to ensure proper use of those medicines.

Key Dates
Posted Date

April 30, 2012

Open Date (Earliest Submission Date)

May 10, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

June 15, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July, 2012

Advisory Council Review

September, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

June 16, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from FDA or the NIH the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

CDER/OCOMM is open to a project based on an existing outreach program of a non-profit that will enhance CDER strategic messaging and formative research to support that messaging. Project (s) must inform about at least one major drug topic such as drug safety, safe use of medicines, medication adherence, and so on. Additionally, the project(s) may include a range of public relations campaign approaches including broadcast media, partner organizations, websites, brochures, other print products, social networks, podcasts, videos, and other media.

Project (s) may involve a third-party, such as a collaboration with a major broadcasting entity, to produce medical or health-related programming to further syndicate, amplify, and deliver messages to audiences that will benefit from medical and health information based on the work of CDER.

All projects must clearly demonstrate a metrics driven model to create a sound rationale for all communication efforts supported by this Cooperative Agreement. The project(s) must also demonstrate the sound use of metrics to establish baseline understandings of the problems being addressed and must provide follow-up evaluation to demonstrate at least rudimentary results. Audience numbers from a broadcast program will also be a useful tool for establishing reach and Google Analytics reports can be used to establish web or social media usage and/or reach.

Funds for this program must advance CDER innovation and impact how the public obtains sound information about the medicines they purchase and take responsibly. Funds may be used to assist healthcare providers in better communicating about medicines to their patients.

Alignment with the FDA and CDER Strategic Plan

All proposals must support FDA strategic initiatives and the mission of CDER:

The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities from pre-market review of efficacy and safety to post-market product surveillance to review of product quality.

For more information about FDA and CDER, please visit the FDA website at: http: //

Measuring Communications Results: Outputs and Outcomes

CDER's Office of Communications seeks to collaborate on a communications program that will lead to annual outputs and longer-term outcomes. Outputs and outcomes for this program differ both in their nature, and in how they are measured.

Outputs: The term output for this announcement means a communications activity, effort and/or associated products related to a communications goal and objective that will be produced or provided over a period of time or by a specified date. Outputs may be quantitative or qualitative but must be measurable during an assistance agreement funding period. Proposals must include a description of how the assistance agreement recipient will track progress towards a communications goal throughout the project period.

Outcomes: The term outcome means the result, effect or consequence that will occur from disseminating a communications program or activity that is related to a communications or programmatic goal or objective. Outcomes may be environmental, behavioral, health-related or programmatic in nature, but must be quantifiable. They may not necessarily be achievable within an assistance agreement funding period. Proposals must include a description of project outcomes resulting from the project outputs.

Expected outcomes from projects funded under this solicitation may include but are not limited to the following:

Short-term outcomes such as increased understanding of the public health issue pertaining to human drugs; dissemination of the increased knowledge via listserves, websites, journals and outreach events, including broadcast; and fine-tuned and improved use of communications technology.

Medium-term outcomes may include widespread adoption of safe use of medicine practices or safe handling of human drug products by key target audiences or widespread discussion about key human drug messaging on point and demonstrating changes in key perceptions

Long-term outcomes may include reductions in deaths from unsafe use of medicines or adverse event reports that may indicate human error in administering or taking medicines.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed


The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

CDER intends to commit $200,000 in FY 2012. Only one grant will be funded.

Award Budget

Application budgets are limited to $200,000 (Total Cost) in the first year and $500,000 in subsequent years up to 5 years depending on the availability of funds. The budgets need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 5 years.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

CDER recognizes and endorses the need for full and open competition, and by preference utilizes open competition in the vast majority of its initiatives. For the CDER Strategic Communication Outreach funding opportunity announcement, CDER seeks creative communications approaches to many of the significant public health problems it has identified. Historically non-profits have developed the membership and broad audience outreach, including the elderly, children, healthcare professionals and young adults, that CDER is seeking. Such public/private partnerships make tremendous strides in changing or re-enforcing public beliefs about the risks and benefits, safe use, and sound practices of medical products, especially human drugs.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application contains a distinct, comprehensive communications plan.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Not Applicable

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan as provided in the SF424 (R&R) Application Guide, with the following modifications:


Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA?

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Grants Management Office and responsiveness by components of participating organizations, FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described below:

the only post-submission grant application materials that the FDA will accept are those resulting from unforeseen administrative issues.  Post-submission grant application materials are those submitted after submission of the grant application but prior to the initial peer review.  This option is to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, not to correct oversights/errors discovered after submission of the application.

Acceptable post-submission materials include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution (e.g., PI moves to another university)

News of an article accepted for publication (a copy of the article should not be sent)

Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:

Updated Specific Aims or Programmatic Strategy pages

Late-breaking findings

New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the FDA Mission, all applications submitted to the FDA are evaluated for programmatic, scientific and technical merit through the FDA review process.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the communication field involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major impact. For example, a project that by its nature is not innovative may still have a major impact on public health.


Does the project address an important problem or a critical barrier to progress in public health? If the aims of the project are achieved, how will public health knowledge, technical capability and FDA communications practice benefit or improve? How will successful completion of the aims change the concepts, methods, technologies, services, or preventative interventions that drive this field?

Program Managers/Principal Investigator(s)

Are the PD(s)/PI(s), collaborators, and other principals well suited to the project? Do all principals they have appropriate experience and training? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the principals have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?


Does the application challenge and seek to shift current communication paradigms by utilizing novel theoretical concepts, approaches or methodologies?


Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? 


Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the project principals adequate for the project proposed? Will the project benefit from unique features of the environment or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.


Not Applicable


Not Applicable


Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Not Applicable

Resource Sharing Plans

Not Applicable.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed project activity.

2. Review and Selection Process

Applications will be evaluated for programmatic and technical merit by (an) appropriate Ad Hoc Review Group(s), in accordance with FDA review policies and procedures, using the stated review criteria.

As part of the programmatic and scientific review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to CDER. Following initial review, recommended applications will receive a second level review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) electronically via e-mail through the Grants Management Office. 

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award.

Cooperative Agreement Terms and Conditions of Award

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their work.

An agency Program Official or Project Officer will be responsible for the normal technical and programmatic stewardship of the award and will be named in the NoA.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi-annually by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the FDA's purpose is to support and stimulate the recipients activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. 

FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to on-site monitoring and participation in planning meetings and other conferences.

Program Director/Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award.  This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

Awardees will retain custody of and have primary rights to the data, media and products developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

The PD(s)/PI(s) will have the primary responsibility for:

1. Overall management of the project

2. Agreement to work cooperatively

3. Development and implementation of systems necessary for communications among the various study organizational components.

All data, media and products will be shared freely by methods and within time periods to be specified by the Project Officer.

Awardees will retain custody of and have primary rights to the data and media developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

Project Officer Responsibilities:

FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The designated FDA Project Officer will serve as a member of any established Steering Committee and have substantial technical/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The awardees agree to accept assistance from the designated FDA Project Officer. This person will participate, in the monitoring of issues relating to recruitment, follow-up, and adherence to project plans and will assist in the development and/or adjustment of project activity

Additionally, an agency program official may be responsible for the normal technical and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

If a Steering Committee, is established it should be comprised of comprised of the PD(s)/PI(s) of the cooperative agreement, the leaders of additional performance sites, the FDA Project Officer, and/or the FDA agency program official will have primary responsibility for finalizing standard procedures communication plans for all funded projects. The steering committee will meet every three to six months, or as dictated by the needs of the project. Each full member of the Steering Committee will have one vote, and all major decisions will be determined by majority vote of the Steering Committee. Awardees will be required to accept and implement policies approved by the Steering Committee.

The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of project activity and policy decisions and will define the rules regarding access to media and distribution.

Dispute Resolution:

Any disagreements that may arise in technical or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardees. This special dispute resolution procedure does not alter the awardees' right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement

A final progress report, program development statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts Customer Support (Questions regarding registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-827-7175

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939

Project Officer Contact(s)

Kimberly Rawlings, Deputy Director
Telephone: 301-796-3818

Programmatic Contact(s)

Elaine Frost, COR
Food and Drug Administration
Telephone: 301-796-3174

Financial/Grants Management Contact(s)

Gladys Melendez
Food and Drug Administration
Office of Acquisitions and Grant Services
5630 Fishers Lane, HFA 500; Rm. 1078
Telephone: 301-827-7175

Section VIII. Other Information

A full list of policy notices published by FDA or NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and The statutory authority for the FDA and CDER is based on the Federal Food, Drug and Cosmetic Act of 1906 and all subsequent Amendments form the legal basis for the work of FDA and CDER, as well as all the other FDA Centers. An on-line version of the Act may be found at the FDA website:

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