Form FDA 3674 - Certifications To Accompany Drug, 
Biological Product, and Device 
Applications/Submissions:  
 
GUIDANCE FOR SPONSORS, INDUSTRY, RESEARCHERS, 
INVESTIGATORS, AND FOOD AND  
DRUG ADMINISTRATION STAFF  
 
 
Additional copies are available from: 
Office of Good Clinical Practice, Office of Special Medical Programs 
Food and Drug Administration 
WO Bldg. 32, Room 5172  
 10903 New Hampshire Avenue 
Silver Spring, MD, 20993-0002 
301-796-8340 
gcp.questions@fda.hhs.gov 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice, Office of Special Medical Programs 
Revised June 2017 
 
OMB Control No. 0910-0616 
See additional PRA statement in Section IV of this guidance.    Contains Nonbinding Recommendations 
 
Form FDA 3674 - Certifications To Accompany Drug, Biological 
Product, and Device Applications/Submissions 
 
Guidance for Sponsors, Industry, Researchers,  
Investigators, and Food and Drug Administration Staff 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 
discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title 
page. 
 
 
 
 
I.  Introduction  
 
This guidance describes the Food and Drug Administrations (FDA, we, or Agency) current 
thinking regarding the types of applications and submissions that sponsors, industry, researchers, 
and investigators submit to FDA with accompanying certifications (Form FDA 3674) under 
section 402(j)(5)(B) of the Public Health Service Act (PHS Act), 42 U.S.C.  282(j)(5)(B).  
Section 402(j) of the PHS Act was added by Title VIII, Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Public Law 110-85).      
 
FDAs guidance documents, including this guidance, do not establish legally enforceable rights 
or responsibilities.  Instead, guidances describe FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
    1  Contains Nonbinding Recommendations 
 
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
 
II.  Background 
 
Title VIII, FDAAA, amended the PHS Act by adding section 402(j), 42 U.S.C.  282(j).  The 
provisions require that additional information be submitted to the clinical trials data bank 
(www.ClinicalTrials.gov) operated by the National Institutes of Health (NIH)/National Library 
of Medicine (NLM), including expanded information on clinical trials and summary information 
regarding the results of clinical trials.  
 
One provision, 42 U.S.C.  282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, requires that a 
certification accompany certain human drug, biological product, and device applications and 
submissions to FDA.  The provision reads as follows:  
 
(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL 
PRODUCT, AND DEVICE SUBMISSIONS.At the time of submission 
of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, 
section 515 of such Act, section 520(m) of such Act, or section 351 of this Act, 
or submission of a report under section 510(k) of such Act, such application or 
submission shall be accompanied by a certification that all applicable 
requirements of this subsection have been met. Where available, such certification 
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shall include the appropriate National Clinical Trial control numbers. 
 
The certification requirement went into effect on December 26, 2007.  To assist sponsors, 
industry, researchers, and investigators in complying with the requirement, we created a 
certification form (Form FDA 3674) to be used to satisfy the certification requirement.  The 
Form FDA 3674 can be obtained at: 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm  
III. Purpose and Agency Recommendations 
 
We received numerous inquiries asking whether various kinds of information and documents that 
sponsors, industry, researchers, and investigators submit to FDA must be accompanied by the 
certification (Form FDA 3674).  We also have experience with the submission of certifications 
since the form was implemented in December 2007.  This guidance provides FDAs current 
thinking, for purposes of continued implementation of Title VIII of FDAAA,1 regarding specific 
types of applications and submissions submitted to FDA under section 505, 515, 520(m), or 
510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), or under section 351 of 
the PHS Act, and accompanying certifications described in section 402(j)(5)(B), 42 U.S.C 
 282(j)(5)(B).     
 
                                                 
1 In particular, the Agencys discussion of applications and submissions in this guidance is not necessarily 
applicable to any other provision of law.  
    3  Contains Nonbinding Recommendations 
 
The purpose of Title VIII, FDAAA, is to provide a means for ensuring that the public has access 
to information about certain clinical trials.2  Specifically, Title VIII is intended to provide a 
mechanism for the public to learn about certain clinical trials that are being conducted, as well as 
summary results information of those trials.  In determining its current thinking on specific 
applications and submissions submitted under the statutory sections cited above and submission 
of accompanying certifications, FDA has focused on the role the certification plays in helping 
achieve the purposes of Title VIII, FDAAA.   
 
One purpose of the certification is to require the submitter to confirm compliance with all 
applicable requirements of Title VIII, including  applicable implementing regulations, e.g., the 
requirement to register applicable clinical trials.3  Failure to submit a certification, knowingly 
submitting a false certification, failure to submit required clinical trial information, and 
submission of clinical trial information that is false or misleading are all prohibited acts under 
section 301(jj) of the FD&C Act (21 U.S.C.  331(jj)).4  Requiring a certification (Form FDA 
3674) to accompany certain applications and submissions submitted to FDA is, therefore, one 
way of encouraging compliance with the provisions of the law and any applicable implementing 
regulations. 
                                                 
2 Since implementation of the Form FDA 3674, FDA has promulgated 21 CFR  50.25(c), requiring a statement in 
certain informed consent documents concerning the submission of information to the databank at 
www,ClinicalTrials.gov.  In addition, on September 21, 2016, NIH published a Final Rule implementing section 
402(j) of the PHS Act (42 U.S.C.  282(j)) (see, 42 CFR part 11).  The Final Rule does not include provisions 
related to this FDA certification other than identifying potential enforcement penalties for failure to comply with 
section 402(j) of the PHS Act (42 U.S.C.  282(j)) (see, 42 CFR 11.66). 
3 Applicable clinical trial is defined at section 402(j)(1)(A)(i) of the PHS Act (42 U.S.C.  282(j)(1)(A)(i)) and at 
42 CFR 11.10.  For additional information, visit http://prsinfo.clinicaltrials.gov.  
4 See, also, 42 CFR 11.66 for legal consequences of failure to comply. 
    4  Contains Nonbinding Recommendations 
 
The certification (Form FDA 3674) also facilitates FDAs exercise of its responsibilities under 
the law.  For example, as stated previously, FDAAA created four prohibited acts relating to 
compliance with the requirements of Title VIII, including compliance with the requirement to 
submit a certification.  The certification requirement is critical to our ability to determine 
whether the law has been complied with and whether an enforcement action is appropriate.  In 
addition, section 402(j)(3)(F) of the PHS Act (42 U.S.C.  282(j)(3)(F)) requires FDA to notify 
the Director of NIH of certain actions taken on applications and reports that were accompanied 
by a certification.  The notification alerts NIH to the fact that the responsible party must submit 
summary results information for the trials within a certain period of time, thereby assisting NIH 
in the exercise of its responsibilities under Title VIII.  The information provided in the 
certification form helps us assist NIH in linking information posted on FDAs website 
regarding certain FDA regulatory actions to specific applicable clinical trials included in the 
registry and results databases.  This linking, using the information in Form FDA 3674, 
particularly the NCT (National Clinical Trial) number(s) required in the form, allows FDA to 
help the public more easily correlate various reports, medical reviews, advisories, health alerts, 
advisory committee actions, and other materials with specific applicable clinical trials registered 
with www.ClinicalTrials.gov  and identified by the NCT number.  
 
New drug applications (NDAs), supplemental NDAs, biologics license applications (BLAs), 
supplemental BLAs, abbreviated new drug applications (ANDAs),  premarket approval 
applications (PMAs), PMA panel track supplements, humanitarian device exemptions (HDEs), 
and resubmissions of these, are all applications under their respective sections of the FD&C 
    5  Contains Nonbinding Recommendations 
 
Act or the PHS Act.  Similarly, 510(k)s are submissions of a report under that section of the 
FD&C Act.  Thus, all of these specified applications and submissions fall within the plain 
language of the statutory provision.  Additionally, these all represent the initiation of the 
regulatory review process through which clinical investigations supporting approval of a 
previously unapproved medical product are submitted to FDA for marketing approval of that 
product.  Because amendments to pending applications, pending supplemental applications, or 
pending submissions of 510(k)s are not independently applications or submissions of a report 
under 510(k), such amendments need not be accompanied by a certification (Form FDA 3674).     
 
We concluded that the statutory requirement to submit a certification also applies to 
investigational new drug applications (INDs) and the submissions of new protocols to INDs.  
INDs are authorized under  505(i) of the FD&C Act (see also 21 C.F.R.  312.3 (defining 
IND as an investigational new drug application)).  We also concluded that Form FDA 3674 
must accompany the submission of a new clinical protocol to an IND as described in 21 CFR  
312.30(a).  There are a number of different types of submissions to an IND that are referred to as 
amendments under FDAs regulations, but these types of submissions are varied as to their 
purpose and the role they play in the regulatory process.  One type of submission is that of a new 
protocol submitted to a pending IND.  A new clinical protocol that is submitted to a pending 
IND, for a study not already included in an existing protocol, is the investigational stage analog 
to an efficacy supplement to an NDA or BLA for a new indication not already covered by the 
existing application.  New protocols are referred to as amendments to INDs, and are submitted to 
existing INDs, as a matter of regulatory process.  We could have required that new protocols 
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filed with FDA be submitted to a new IND, but for administrative ease chose to have them 
submitted to the existing IND.  In contrast, other types of amendments to pending INDs are more 
analogous to amendments to NDAs, BLAs, and PMAs; as such, consistent with our 
interpretation of the statute with regard to amendments to NDAs, BLAs, and PMAs, 
certifications (Form FDA 3674) need not be submitted with IND amendments other than 
submission of a new protocol to an existing IND. 
 
FDA intends to exercise enforcement discretion with regard to submission of certifications with 
four categories of applications and submissions: 1) a supplement to an approved NDA, BLA, or 
PMA other than an efficacy supplement (for NDAs and BLAs) or a panel track supplement (for 
PMAs), 2) a supplement to an approved ANDA, 3) INDs that fall within the types of INDs 
described in section 561 of the FD&C Act (21 U.S.C.  360bbb), and 4) submission of a 510(k) 
if that submission does not refer to, relate to, or include information on or from a clinical trial.  
FDA believes that, in contrast to the types of applications and submissions discussed above, the 
majority of supplements to approved NDAs, BLAs, and PMAs do not refer to, relate to, or 
include information on or from a clinical trial.  Furthermore, even to the extent that, for example, 
a labeling supplement to an approved NDA may refer to, relate to, or include information on or 
from one or more clinical trials, those clinical trials in all likelihood were conducted under an 
IND, and therefore the sponsor would already have submitted a certification (Form FDA 3674) 
regarding those trials during the investigational phase.  It would be repetitive and would serve 
little or no purpose to have a sponsor repeatedly certify to having complied with the 
    7  Contains Nonbinding Recommendations 
 
requirements of Title VIII, FDAAA, including any applicable implementing regulations, with 
regard to the same clinical trial.   
 
With regard to supplements to approved ANDAs, even when such supplements are intended to 
add an additional indication (such as when existing patents or exclusivities have expired), such 
supplements would not ordinarily refer to, relate to, or include information on or from any 
clinical trial other than those which were referenced or referred to in the original ANDA 
submission.  Thus, as with non-efficacy supplements to approved NDAs and BLAs, and panel 
track supplements to approved PMAs, certification with a supplemental ANDA would be 
repetitive, and would serve little or no purpose with regard to ensuring that the requirements of 
Title VIII and any applicable implementing regulations had been met.   
 
With regard to INDs that fall within the types of INDs described in section 561 of the FD&C Act 
(21 U.S.C.  360bbb), for purposes of the certification and completing the Form FDA 3674, the 
clinical trials conducted under such INDs will not be considered an applicable drug clinical trial 
as defined in section 402(j)(1)(A)(iii) of the PHS Act (42 U.S.C.  282(j)(1)(A)(iii)).5 None of 
those trials will be subject to the individual registration and reporting requirements as set forth in 
Title VIII, FDAAA, or 42 CFR part 11.  Because none of the clinical trials conducted under an 
IND of the type described in section 561 of the FD&C Act would be subject to the requirements 
of Title VIII, FDAAA, or 42 CFR part 11, since these are not considered applicable clinical 
                                                 
5 The definition of applicable clinical trial in 42 CFR 11.10 excludes expanded access under section 561 of the 
FD&C Act from the definition of an applicable clinical trial.  
    8  Contains Nonbinding Recommendations 
 
trials, certification with regard to such clinical trials when submitting an IND for such a clinical 
trial would serve little or no purpose with regard to ensuring that the requirements of Title VIII 
or 42 CFR part 11 had been met. 
 
Finally, with regard to 510(k)s, the majority of 510(k) submissions do not refer to, relate to, or 
include information on or from a clinical trial.  Accordingly, FDA believes that certification with 
regard to 510(k) submissions that do not refer to, relate to, or include information on or from a 
clinical trial would serve little or no purpose with regard to ensuring that the requirements of 
Title VIII, FDAAA, or 42 CFR part 11, had been met.   
 
Because FDA believes that the statutory purposes of Title VIII would not be furthered by the 
submission of certifications (Form FDA 3674) with these four categories of applications and 
submissions, we intend to exercise enforcement discretion regarding certification with these 
applications and submissions.  
 
Based on these considerations and as described above, FDA recommends that a certification 
using Form FDA 3674 accompany the following types of applications and submissions: 
 
Applications/Submissions (including Resubmissions) 
IND 
New Clinical Protocol Submitted to an IND  
NDA  
    9  Contains Nonbinding Recommendations 
 
Efficacy Supplement to an Approved NDA 
BLA 
Efficacy Supplement to an Approved BLA 
ANDA 
PMA 
PMA Panel Track Supplement 
HDE 
510(k) that refers to, relates to, or includes information on a clinical trial  
 
IV. Paperwork Reduction Act of 1995 
 
This guidance refers to previously approved collections of information.  These collections of 
information are subject to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C.  3501-3520).  The collections of information 
have been approved under OMB Control No. 0910-0616.    
   
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