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Note 1: Verify whether the applicant 
accurately designated the product as a combination product or not. If designated as a combination product, verify whether the type selected (e.g., CPN, CP1, CP2, etc.) is accurate.  If RPM disagrees with the applicant’s designation or the type of combination, consult with the file Chair and appropriate management and notify the applicant immediately of CBER’s assessment and request a corrected form 356h.If yes, indicate by using Bold which type of 
combination product and contact the Office of Combination Products (OCP) and copy them on all Inter-Center consults (if applicable).
Note 2 : Notification of OCP should only be done 
after verification and applicant notification as 
explained in Note 1.
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arrears status daily and proactively alert affected Offices that applications and supplements should not be received if a firm is in arrears.Indicate the payment for this application by using BOLD:
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Providing Regulatory Submissions 
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16.Electronic forms and certifications with electr onic signatures (scanned, digital, or 
electronic) are acceptable. Forms include user fee cover sheet (3397), application 
form (356h), financial disclosure (3454/3455), and clinical trials (3674); Certifications include: debarment certification and pediatric certification on Pediatric 
Plan for waived or deferred Pediatric studies.
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Forms must be signed by the 
APPLICANT, not an Agent [see 21 CFR 54.2(g)].
Note: Financial disclosure is required 
for bioequivalence studies that are 
the basis for approval.9
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If yes, ensure that the application is 
also coded with the supporting document category, “Certification Form 3674.” 
If no, ensure that language 
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If yes, enter in the appropriate 
regulatory tracking database (RMS/BLA).
If no, request in either the Filing or 
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If yes, refer to CBER JA 900.18: 
Study Data Validation 3URFHVV
Note : The Data Standards 
Representative will email the validation 
reports to the RPM upon completion.The email and validation reports should be attached to the filing checklist when uploading to the CER.9
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900.18: Study Data Validation Process.
Note 1:  If there are errors, collaborate 
with discipline reviewer(s) and the CDISC representative to draft an information request for minor corrections or a refuse to file letter as appropriate. 
Note 2: Review decision regarding 
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Certification is not required for 
supplements if the debarment certification was submitted in the original application. If foreign applicant, both the applicant and the U.S. Agent must sign the certification [per Guidance for Industry: Submitting Debarment Certifications].
Note: Debarment Certification should 
use wording in FD&C Act Section 
306(k)(1) i.e.,“[Name of applicant] hereby certifies that it did not and will not use in any capacity the services of any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act in connection with this application...” Applicant may notuse
wording such as, “To the best of my knowledge…”9
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Check the Orphan Drug Designations and Approvals list at:http://www.accessdata.fda.gov/script
s/opdlisting/oopd/index.cfm
If yes, consult CBER Jurisdiction Officer.  See Jurisdiction intranet site for current CBER contact: http://inside.fda.gov:9003/cber/officeofthedirector/associatedirectorforqualit
yassurance/ucm023543.htm9
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If yes, consult CBER Jurisdiction 
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Exclusivity Period of Reference 
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If yes, email CBER Pediatric 
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Note 1: All waiver & deferral 
requests, pediatric plans, and pediatric assessment studies must be reviewed by PeRC prior to approval of the application/supplement.
Note 2: If the applicant deviated 
from their agreed PSP discuss with Supervisor and Office representative to CBER Pediatrics Working Group.
Note 3: Pediatric items are looked at 
by both the RPM and the Clinical Reviewer.
FDA-CBER-2022-5812-0500333
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PMR #1: Deferred 
pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age.
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Michael J. Smith -S4Digita ly s gned by Michael J  Sm th S4 DN  c=US  o=U S  Government  ou=HHS  ou=FDA  ou=People  0 9 2342 19200300 100 1 1=0014080934  cn=Michael J  Sm th S4 Date  2022 02 07 07 59 10 05'00'
Elizabeth M. Sutkowski -SDigitally signed by El zabeth M  Sutkowski S DN  c=US  o=U S  Government  ou=HHS  ou=FDA  ou=People  0 9 2342 19200300 100 1 1=1300076199  cn=Elizabeth M  Sutkowski S Date  2022 02 07 12 00 37 05 00'
Loris D. Mcvittie -SDigitally signed by Loris D. Mcvittie -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300064781, cn=Loris D. Mcvittie -S Date: 2022.02.07 14:06:18 -05'00'
Laura B. Gottschalk -S 2022.02.09 14:25:04 -05'00'
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