+-----------------------+-----------+-----------+-------+--------------+
| **DEPARTMENT OF       |           | **CERT    |       |              |
| HEALTH AND HUMAN      |           | IFICATION |       |              |
| SERVICES**            |           | OF EXEMPT |       |              |
|                       |           | STATUS**  |       |              |
| **Food and Drug       |           |           |       |              |
| Administration**      |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
| SPONSORING            | REVIEWING |           | IN    |              |
| OFFICE/CENTER         | OFFI      |           | VESTI |              |
|                       | CE/CENTER |           | GATOR |              |
|                       |           |           | NAME  |              |
|                       |           |           | (P    |              |
|                       |           |           | rint/ |              |
|                       |           |           | Type) |              |
+-----------------------+-----------+-----------+-------+--------------+
|                       |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
| PROTOCOL TITLE        |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
|                       |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
| Project is EXEMPT     |           | Project   |       |              |
| under **45 CFR        |           | is EXEMPT |       |              |
| 46.101(b)(1)**        |           | under     |       |              |
|                       |           | **45 CFR  |       |              |
| project is conducted  |           | 46.10     |       |              |
| in educational        |           | 1(b)(3)** |       |              |
| setting               |           |           |       |              |
|                       |           | > Project |       |              |
| Facility name         |           | > uses    |       |              |
|                       |           | > only    |       |              |
| AND                   |           | >         |       |              |
|                       |           |  standard |       |              |
| Only standard         |           | > ed      |       |              |
| educational practices |           | ucational |       |              |
| involved              |           | > tests   |       |              |
|                       |           | >         |       |              |
| Project is EXEMPT     |           | > Project |       |              |
| under **45 CFR        |           | > uses    |       |              |
| 46.101(b)(2)**        |           | > only    |       |              |
|                       |           | > survey  |       |              |
| Project uses only     |           | > p       |       |              |
| standard educational  |           | rocedures |       |              |
| tests                 |           | >         |       |              |
|                       |           | > Project |       |              |
| AND                   |           | > uses    |       |              |
|                       |           | > only    |       |              |
| information is        |           | >         |       |              |
| recorded in such a    |           | interview |       |              |
| manner that subjects\ |           | > p       |       |              |
| **can** **not** be    |           | rocedures |       |              |
| identified, directly  |           | >         |       |              |
| or through            |           | > Project |       |              |
| identifiers           |           | >         |       |              |
|                       |           |  involves |       |              |
| OR                    |           | > only    |       |              |
|                       |           | > public  |       |              |
| > Although subjects   |           | >         |       |              |
| > can be identified,  |           |  behavior |       |              |
| > disclosure of\      |           | > ob      |       |              |
| > information         |           | servation |       |              |
| > obtained could not  |           |           |       |              |
| > place subjects at   |           | AND       |       |              |
| > risk\               |           |           |       |              |
| > of civil/criminal   |           | > The     |       |              |
| > liability or be     |           | >         |       |              |
| > damaging to the     |           |  subjects |       |              |
| > subjects' financial |           | > are     |       |              |
| > standing,           |           | > elected |       |              |
| > employability, or   |           | >         |       |              |
| > reputation          |           | officials |       |              |
|                       |           | >         |       |              |
| Project is EXEMPT     |           | > OR      |       |              |
| under **45 CFR        |           | >         |       |              |
| 46.101(b)(2)**        |           | > Federal |       |              |
|                       |           | > *       |       |              |
| > Project involves    |           | *status** |       |              |
| > only ADULTS         |           | >         |       |              |
| >                     |           | requires, |       |              |
| > State               |           | > without |       |              |
| > [     ]{.underline} |           | > e       |       |              |
| > Age of majority     |           | xception, |       |              |
| > [     ]{.underline} |           | > that    |       |              |
|                       |           | > confid  |       |              |
| AND                   |           | entiality |       |              |
|                       |           | > will be |       |              |
| > Information is      |           | > m       |       |              |
| > recorded in such a  |           | aintained |       |              |
| > manner that         |           | > t       |       |              |
| > subjects\           |           | hroughout |       |              |
| > **can not** be      |           | > the\    |       |              |
| > identified,         |           | >         |       |              |
| > directly or through |           |  research |       |              |
| > identifiers         |           | > and     |       |              |
|                       |           | > t       |       |              |
| OR                    |           | hereafter |       |              |
|                       |           | >         |       |              |
| > Although subjects   |           | > USC     |       |              |
| > can be identified,  |           | > Statute |       |              |
| > disclosure of\      |           | >         |       |              |
| > information         |           |  citation |       |              |
| > obtained could not  |           |           |       |              |
| > place subjects at   |           | Project   |       |              |
| > risk\               |           | is EXEMPT |       |              |
| > of civil/criminal   |           | under     |       |              |
| > liability or be     |           | **45 CFR  |       |              |
| > damaging to the     |           | 46.10     |       |              |
| > subjects' financial |           | 1(b)(4)** |       |              |
| > standing,           |           |           |       |              |
| > employability, or   |           | > Project |       |              |
| > reputation (Cite,\  |           | > uses    |       |              |
| > below, where        |           | > only    |       |              |
| > protections of the  |           | >         |       |              |
| > subjects' rights    |           |  existing |       |              |
| > and\                |           | > pat     |       |              |
| > welfare can be      |           | hological |       |              |
| > found in the        |           | >         |       |              |
| > protocol-page       |           | specimens |       |              |
| > numbers)            |           | >         |       |              |
| >                     |           | > Project |       |              |
| >                     |           | > uses    |       |              |
|                       |           | > only    |       |              |
|                       |           | >         |       |              |
|                       |           |  existing |       |              |
|                       |           | > d       |       |              |
|                       |           | iagnostic |       |              |
|                       |           | > s       |       |              |
|                       |           | peciments |       |              |
|                       |           |           |       |              |
|                       |           | AND       |       |              |
|                       |           |           |       |              |
|                       |           | >         |       |              |
|                       |           | > In      |       |              |
|                       |           | formation |       |              |
|                       |           | > is      |       |              |
|                       |           | >         |       |              |
|                       |           |  recorded |       |              |
|                       |           | > in such |       |              |
|                       |           | > a       |       |              |
|                       |           | > manner  |       |              |
|                       |           | > that    |       |              |
|                       |           | >         |       |              |
|                       |           | subjects\ |       |              |
|                       |           | > **can   |       |              |
|                       |           | > not**   |       |              |
|                       |           | > be      |       |              |
|                       |           | > id      |       |              |
|                       |           | entified, |       |              |
|                       |           | >         |       |              |
|                       |           |  directly |       |              |
|                       |           | > or      |       |              |
|                       |           | > through |       |              |
|                       |           | > id      |       |              |
|                       |           | entifiers |       |              |
|                       |           | >         |       |              |
|                       |           | > OR      |       |              |
|                       |           | >         |       |              |
|                       |           | > The     |       |              |
|                       |           | > source  |       |              |
|                       |           | > is      |       |              |
|                       |           | >         |       |              |
|                       |           |  publicly |       |              |
|                       |           | >         |       |              |
|                       |           | available |       |              |
|                       |           |           |       |              |
|                       |           | Project   |       |              |
|                       |           | is EXEMPT |       |              |
|                       |           | under     |       |              |
|                       |           | **45 CFR  |       |              |
|                       |           | 46.10     |       |              |
|                       |           | 1(b)(5)** |       |              |
|                       |           |           |       |              |
|                       |           | > project |       |              |
|                       |           | > is      |       |              |
|                       |           | > Dep     |       |              |
|                       |           | artmental |       |              |
|                       |           | > (HHS)   |       |              |
|                       |           | > study   |       |              |
|                       |           | > to      |       |              |
|                       |           | > examine |       |              |
|                       |           | >         |       |              |
|                       |           | > Public  |       |              |
|                       |           | > benefi  |       |              |
|                       |           | t/service |       |              |
|                       |           | >         |       |              |
|                       |           |  programs |       |              |
|                       |           | >         |       |              |
|                       |           | > P       |       |              |
|                       |           | rocedures |       |              |
|                       |           | > for     |       |              |
|                       |           | >         |       |              |
|                       |           | obtaining |       |              |
|                       |           | > benefit |       |              |
|                       |           | s/service |       |              |
|                       |           | >         |       |              |
|                       |           | >         |       |              |
|                       |           |  Possible |       |              |
|                       |           | > pro     |       |              |
|                       |           | grammatic |       |              |
|                       |           | > changes |       |              |
|                       |           | >         |       |              |
|                       |           | >         |       |              |
|                       |           |  Possible |       |              |
|                       |           | > benefit |       |              |
|                       |           | > payment |       |              |
|                       |           | > changes |       |              |
|                       |           |           |       |              |
|                       |           | Project   |       |              |
|                       |           | is EXEMPT |       |              |
|                       |           | under     |       |              |
|                       |           | **45 CFR  |       |              |
|                       |           | 46.10     |       |              |
|                       |           | 1(b)(6)** |       |              |
|                       |           |           |       |              |
|                       |           | > Project |       |              |
|                       |           | > uses    |       |              |
|                       |           | > only    |       |              |
|                       |           | > food    |       |              |
|                       |           | > taste   |       |              |
|                       |           | > tests   |       |              |
|                       |           | >         |       |              |
|                       |           | > Project |       |              |
|                       |           | > uses    |       |              |
|                       |           | > only    |       |              |
|                       |           | > food    |       |              |
|                       |           | > quality |       |              |
|                       |           | > e       |       |              |
|                       |           | valuation |       |              |
|                       |           | >         |       |              |
|                       |           | > Project |       |              |
|                       |           | > is a    |       |              |
|                       |           | >         |       |              |
|                       |           |  consumer |       |              |
|                       |           | > a       |       |              |
|                       |           | cceptance |       |              |
|                       |           | > study   |       |              |
|                       |           | > (food)  |       |              |
|                       |           |           |       |              |
|                       |           | AND       |       |              |
|                       |           |           |       |              |
|                       |           | > Only    |       |              |
|                       |           | >         |       |              |
|                       |           | wholesome |       |              |
|                       |           | > foods   |       |              |
|                       |           | > without |       |              |
|                       |           | >         |       |              |
|                       |           | additives |       |              |
|                       |           | > are     |       |              |
|                       |           | > used    |       |              |
|                       |           | >         |       |              |
|                       |           | > OR      |       |              |
|                       |           | >         |       |              |
|                       |           | > Food    |       |              |
|                       |           | > in      |       |              |
|                       |           | gredients |       |              |
|                       |           | > are at  |       |              |
|                       |           | > or      |       |              |
|                       |           | > below a |       |              |
|                       |           | > safe    |       |              |
|                       |           | > level   |       |              |
|                       |           | > and for |       |              |
|                       |           | > a use   |       |              |
|                       |           | >         |       |              |
|                       |           | > Found   |       |              |
|                       |           | > to be   |       |              |
|                       |           | > safe by |       |              |
|                       |           | > FDA,    |       |              |
|                       |           | > EPA, or |       |              |
|                       |           | > USDA    |       |              |
+-----------------------+-----------+-----------+-------+--------------+
| > In accordance with  |           |           |       |              |
| > FDA's Multiple      |           |           |       |              |
| > Project Assurance   |           |           |       |              |
| > (M-1441) with the   |           |           |       |              |
| > Department of       |           |           |       |              |
| > Health and Human    |           |           |       |              |
| > Services, I have\   |           |           |       |              |
| > reviewed the        |           |           |       |              |
| > attached study      |           |           |       |              |
| > protocol and have   |           |           |       |              |
| > determined that the |           |           |       |              |
| > protocol includes   |           |           |       |              |
| > adequate provisions |           |           |       |              |
| > for the protection  |           |           |       |              |
| > of the\             |           |           |       |              |
| > rights and welfare  |           |           |       |              |
| > of prospective      |           |           |       |              |
| > research subjects   |           |           |       |              |
| > and that it is      |           |           |       |              |
| > exempt from the     |           |           |       |              |
| > regulations for the |           |           |       |              |
| > protection of human |           |           |       |              |
| > subjects\           |           |           |       |              |
| > (45 CDR part 46) as |           |           |       |              |
| > indicated above.    |           |           |       |              |
| >                     |           |           |       |              |
| >                     |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
| SIGNATURE *(Center    |           |           |       | DATE         |
| Director)*            |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+
|                       |           |           |       |              |
+-----------------------+-----------+-----------+-------+--------------+

+-----------------------------------------------------------------------+
| > **INSTRUCTIONS FOR USING\                                           |
| > FDA CERTIFICATION OF EXEMPT STATUS**                                |
| >                                                                     |
| > FDA, as an agency of the Department of Health and Human Service     |
| > (HHS), is governed by the regulations for the protection of human   |
| > subjects (45 CFR 46). Under the Agency's MPA, Center Directors may, |
| > after appropriate review, certify that a project is exempt from the |
| > HHS regulations. The Center Director may personally conduct their   |
| > view or may direct that the review be conducted by the Center's     |
| > scientific review committee. The certification form includes the    |
| > exemptions \[45 CFR 46.101(b)(1-6)\] and permits documentation of   |
| > the applicability of the exemption. The investigator is responsible |
| > for ensuring that the determination is made and documented.         |
| > Offices/Centers that fund/support research must require             |
| > documentation of exemption or ensure that the requirements of the   |
| > HHS regulations have been complied with before approval to begin is |
| > given.                                                              |
| >                                                                     |
| > Each proposal/protocol for FDA-supported research which involves    |
| > human subjects should contain a section which specifically          |
| > describes issues related to the involvement of the subjects in the  |
| > research (such as: study population/demographics;                   |
| > recruitment/compensation; consent procedures; risk and benefit      |
| > description; and, any sensitive issues/concerns, e.g., use of       |
| > special populations). This section should be completed for all      |
| > research which proposes to use humans in any way. The               |
| > proposal/protocol should also describe the type and extent of human |
| > subject involvement (procedures). The information presented in the  |
| > proposal/protocol should support the determination of exempt        |
| > status.                                                             |
| >                                                                     |
| > **INSTRUCTIONS:**                                                   |
| >                                                                     |
| > **Sponsoring Office/Center:** Title and mail-code of group          |
| > requesting proposal                                                 |
| >                                                                     |
| > **Reviewing Office/Center:** Title and mail-code of group           |
| > submitting proposal                                                 |
| >                                                                     |
| > **Investigator Name:** Name, degrees and title of Principal         |
| > Investigator                                                        |
| >                                                                     |
| > **Protocol Title:** Title as it appears on the application          |
| >                                                                     |
| > **Exemptions:** Check the box(es) for the exemption(s) that apply   |
| > to the research. Then check the applicable boxes under the          |
| > exemption heading to document why the exemption applies. Note: the  |
| > text of the proposal/protocol must support these declarations. Also |
| > note that, except for exemption (5), each exemption requires at     |
| > least two conditions to be met before the exemption can apply.      |
| > Requirements that are \"and/or\" maybe met if either condition      |
| > exists. Exemption (2) is the most frequently cited exemption, but   |
| > it is also the most complex, as three conditions must be met.       |
| > Except for educational tests, this exemption cannot be used if any  |
| > of the subjects will be children. Note that the definition (age) of |
| > adult/children is determined by the state law at the performance    |
| > site (where the subjects will participate).                         |
| >                                                                     |
| > **Signature:** The signature of the Center director or, if          |
| > authorized, the Chair of the Center's scientific review committee.  |
| >                                                                     |
| > The Office of Health Affairs is the Agency's contact point for      |
| > human subject issues and is available for consultation. FDA         |
| > personnel may contact OHA, Health Assessment Policy Staff (HFY-20)  |
| > at (301) 827-1685 for further information and/or assistance.        |
+-----------------------------------------------------------------------+