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General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

OMB: 0910-0338

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United States Food and Drug Administration
General Licensing Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Form FDA 356h
OMB Control No. 0910-0338
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration (FDA) regulations
regarding biologics license applications, changes to approved applications, labeling, revocation and
suspension postmarketing studies status reports, and agency Form FDA 356h.
Under section 351 of the Public Health Services Act (the PHS Act) (42 U.S.C. 262), manufacturers
of biological products must submit a license application for FDA review and approval before
marketing a biological product in interstate commerce. Licenses may be issued only upon showing
that the establishment and the products for which a license is desired meets standards prescribed in
regulations designed to ensure the continued safety, purity, and potency of such products. All such
licenses are issued, suspended, and revoked as prescribed by regulations in 21 CFR Part 601.
Section 130(a) of the Food and Drug Administration Modernization Act of 1997 (Public Law 105115) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act,) by adding a new
provision, section 506B of the FD&C Act (21 U.S.C. 356b), requiring reports of postmarketing
studies (PMSs) for approved human drugs and licensed biological products. Section 506B of the
FD&C Act provides FDA with additional authority to monitor the progress of PMSs that applicants
have made a commitment to conduct and requires the Agency to make publicly available
information that pertains to the status of these studies. Under section 506B(a) of the FD&C Act,
applicants that have committed to conduct a PMS for an approved human drug or licensed
biological product must submit to FDA a status report of the progress of the study or the reasons
for the failure of the applicant to conduct the study. This report must be submitted within 1 year
after the U.S. approval of the application and then annually until the study is completed or
terminated.
FDA therefore requests an extension of OMB approval of the reporting and third-party disclosure
provisions found in 21 CFR Parts 600, 601, 610, 640, 640, and 680 as discussed in this supporting
statement.
2. Purpose and Use of the Information Collection
The collection of information will be used by FDA to monitor industry procedures and discharge
its statutory responsibility for protecting the nation’s health. The PHS Act and FDA regulations
require manufacturers to submit a license application for review and approval prior to marketing a
biological product in interstate commerce. In addition, applicants must submit to FDA advertising

 

and promotional labeling. Manufacturers or applicants or are also required to submit changes,
including labeling, changes to an approved application, as well as advertising and promotional
labeling changes. The information submitted to FDA in a biologics license application (BLA),
supplement to an approved application, or other similar submission is used to determine if a
product is safe, effective, and not misbranded under prescribed, recommended, or suggested
conditions of use. The regulations also describe the types of postmarketing studies that require
status reports, the information to be included in the reports, and the type of information that FDA
would consider appropriate for public disclosure. FDA uses the information submitted from PMS
reports to meet its reporting obligations under section 506B of the FD&C Act and section 130(b) of
the Food and Drug Administration Modernization Act.
3. Use of Improved Information Technology and Burden Reduction
One of FDA’s continuing objectives is to improve the speed and quality of its review and approval
programs. In order to reach a decision to approve an application, the agency must evaluate all
information and data provided by applicants on the safety, purity, potency, and efficacy of the
proposed product. To make the review process more efficient for industry and FDA, CBER and
CDER are utilizing electronic information systems technology. CBER and CDER currently accept
the submission of electronic license applications. FDA believes the increased use of computerassisted license applications will enhance the timeliness, effectiveness, and efficiency of the review
process and reduce burdensome, nonessential hard-copy handling and storage. FDA is not aware
of any other improved technology to reduce the burden.
4. Effects to Identify Duplication and Use of Similar Information
Due to FDA’s Regulatory responsibilities, FDA is the only agency that requires the filing of an
application for the marketing of a biological product for human use, any changes to an approved
application, and other required information. No other government agencies require similar
information or data to be submitted. This information is not available from any other source.
5. Impact on Small Businesses or Other Small Entities
This collection of information applies to small as well as large establishments. Although FDA
must apply the statutory and regulatory requirements equally to all enterprises, the agency does
provide special help to small businesses. The Center for Biologics Evaluation and Research
(CBER), Office of Communication, Outreach, and Development, Division of Manufacturers
Assistance and Training and CDER’s Office of Communication Division of Drug Information
provide assistance to small businesses subject to FDA’s regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
Manufacturers are required to submit applications for approval of biological products prior to
marketing such products in interstate commerce. In addition, manufacturers are required to submit
a supplement to an approved application prior to implementing a change or in an annual report,
depending on the significance of the change. Less frequent collection of this and other information
will not provide the information that FDA needs to evaluate the safety, purity, potency, and
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effectiveness of a biological product and properly monitor the progress of postmarketing studies.
There are no technical or legal obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
An applicant may be required to submit to FDA proprietary trade secret or other confidential
information when submitting a license application, change to an approved application, or an annual
report. FDA protects confidential information received from manufacturers to the extent permitted
by law. In addition, certain changes to an approved application are required to be submitted each
time a change is made. This information is necessary for FDA to ensure that the proposed changes
do not have an adverse effect on the strength, quality, purity, or potency as they may relate to the
safety and effectiveness of a product.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
FEDERAL REGISTER of September 19, 2019 (84 FR 49310). No comments were received.
9. Explanation of Any Payment or Gift to the Respondents
There are no incentives, payments, or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
This Information Collection Request collects personally identifiable information (PII) or other data
of a personal nature. PII is collected in the context of the subject individuals’ professional capacity
and the FDA-related work they perform for their employer (e.g., point of contact). The PII
submitted for Form FDA 356h (Application to Market a New or Abbreviated New Drug or Biologic
for Human Use) is name, address, telephone number, email address and fax number.
FDA further determined this collection is not subject to the Privacy Act of 1974 and the particular
notice and other requirements of the Act do not apply. Specifically, FDA does not use name or any
other personal identifier to routinely retrieve records from the information collected.
In preparing this Supporting Statement, FDA staff consulted with the FDA Privacy Office to ensure
appropriate handling of information collected. FDA minimized the PII to be collected to protect
the privacy of the individuals.
The confidentiality of information received by FDA would be consistent with the Freedom of
Information Act (FOIA) and FDA’s regulations under 21 CFR Part 20, 21 CFR 601.51, and
601.70(e).
 

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11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden for this information collection as follows:

 

TABLE
APPEARS
ON NEXT
PAGE

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Table 1 – Estimated Annual Reported Burden
21 CFR Section

601.2(a) 1, 610.60
through 610.651
601.5(a)
601.6(a)
601.12(a)(5)
601.12(b)(1)/(b)(3)/(e) 3
601.12(c)(1)/(c)(3) 4
601.12(c)(5)
601.12(d)(1)/(d)(3)
5/(f)(3)7
601.12(f)(1)6
601.12(f)(2) 6
601.12(f)(4)/601.458
601.27(b)
601.27(c)
601.70(b)
and
610.15(d)
680.1(c)
680.1(b)(3)(iv)
Amendments/
Resubmissions

Form
FDA
No.

No. of
Respondents

No. of
Responses
per
Respondent

Avg.
Burden
per
Response

Total
Annual
Responses

Total
Hours10

356h

36

1.28

46

860

NA
NA
NA
356h1
356h1
356h1
356h1

8
1
430
166
149
7
245

1.13

9
1

4.158
4.843
4.58
1.14
3.575

1,788
804
682

0.33
0.33
1
80
50
50
24

1,788
64,320
34,100
400
21,024

2253
2253
2253
NA
NA
2252

65
43
134
12
2
65

3.169
2.05
145.86
1.08
1.00
3.169

206
88
19,545
13
2.00
206

40
20
10
24
8
24

8,240
1,760
195,450
312
16
4,944

NA
NA
NA
356h

1
9
1
136

1
9
1

1
2
2
20

1
18
2

1

8
876

1
1
1
24.985

3,398

39,560
3
1

67,960

27,683
439,899
1 The reporting requirements under 21 CFR 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a),
640.17, 640.25(c), 640.56(c), 640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the
estimate under 21 CFR 601.2(a).
2 The reporting requirements under 21 CFR 601.93(b)(3), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a),
660.2(c), 660.28(a), (b), and (c), 660.35(a) through (d), 660.45, and 660.55(a) and (b) are included under 21
CFR 610.60 through 610.65.
3 The reporting requirements under 21 CFR 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(b), 606.110(b),
640.6,
640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are
included in the
estimate under 21 CFR 601.12(b).
4 The reporting requirements under 21 CFR 601.12(a)(2), 610.9(a) 640.17, 640.25(c), 640.56(c), and
640.74(b)(2) are included in the estimate under 21 CFR 601.12(c).
5 The reporting requirement under 21 CFR 601.12(a)(2) is included in the estimate under 601.12(d).
6 The reporting requirement under 21 CFR 601.14 is included in the estimate under 21 CFR 601.12(f)(1) and (2).
7 The reporting requirement under 21 CFR 601.12(a)(4) and 601.14 is included in the estimate under 601.12(f)(3).
8 The reporting requirement under 21 CFR 601.94 is included in the estimate under 21 CFR 601.45.
9 The numbers in this column have been rounded to the nearest whole number.

 

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Table 2 – Estimated Annual Third-Party Disclosure Burden
21 CFR
Section

No. of
Respondents

No. of
Disclosures
per
Respondent

Total Annual
Disclosures

Average
Burden per
Disclosure

1
Total Hours

601.6(a)

1

20

20

0.33
(20 minutes)

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Respondents to this collection of information are manufacturers of biological. In tables 1 and 2, the
numbers of respondents are based on the estimated annual number of manufacturers that submitted
the required information to FDA or the number of submissions FDA received in fiscal year 2018.
The total annual responses are based on the estimated number of submissions (i.e., license
applications, labeling and other supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The hours per response are based
on information provided by industry and past FDA experience with the various submissions or
notifications. The hours per response include the time estimated to prepare the various submissions
or notifications to FDA, and, as applicable, the time required to fill out the appropriate form and
collate the documentation. Additional information regarding these estimates is provided below as
necessary.
The applicable information collection requirements under 21 CFR Parts 600, 601, 610, 640, 640,
and 680 are as follows:
21 CFR 600.15(b), 610.53(d); Reporting: requires the submission of a request for an exemption or
modification regarding the temperature requirements during shipment and from dating periods,
respectively, for certain biological products.
21 CFR 601.2(a) and 610.60 through 610.65; Reporting: requires a manufacturer of a biological
product to submit an application on forms prescribed for such purposes with accompanying
information, including certain labeling information, to FDA for approval to market a product in
interstate commerce.
21 CFR 601.5(a); Reporting: requires a manufacturer to submit to FDA notice of its intention to
discontinue manufacture of a product or all products.
21 CFR 601.6(a); Reporting/Disclosure: requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such notification.
21 CFR 601.12(a)(2); Reporting: requires, generally, that the holder of an approved biologics
license application must assess the effects of a manufacturing change before distributing a
biological product made with the change.
21 CFR 601.12(a)(4); Reporting: requires, generally, that the applicant must promptly review all
promotional labeling and advertising to make it consistent with any labeling changes implemented.
21 CFR 601.12(a)(5); Reporting: requires the applicant to include a list of all changes contained in
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the supplement or annual report; for supplements, this list must be provided in the cover letter.
21 CFR 601.12(b)(1)/(b)(3), 601.12(c)(1)/(c)(3), 601.12(c)(5), and 601.12(d)(1)/(d)(3);
Reporting: requires applicants to follow specific procedures to submit information to FDA of any
changes, in the product, production process, quality controls, equipment, facilities, or responsible
personnel established in an approved license application. The appropriate procedure depends on
the potential for the change to have a substantial, moderate, or minimal adverse effect on the
identity, strength, quality, purity, or potency of the products as they may relate to the safety or
effectiveness of the product.
21 CFR 601.12(b)(4); Reporting: applicant may ask FDA to expedite its review of a supplement
for public health reasons or if a delay in making the change described in it would impose an
extraordinary hardship of the applicant.
21 CFR 601.12(e); Reporting: requires applicants to submit a protocol, or change to a protocol, as
a supplement requiring FDA approval before distributing the product.
21 CFR 601.12(f)(1), 601.12(f)(2), 601.12(f)(3); Reporting: requires applicants to follow specific
procedures to report certain labeling changes to FDA.
21 CFR 601.12(f)(4); Reporting: requires applicants to report to FDA advertising and promotional
labeling and any changes.
21 CFR 601.14; Reporting: requires the content of labeling required in 21 CFR 201.100(d)(3)
must be in electronic format and in a form that FDA can process, review, and archive.
21 CFR 601.27(a); Reporting: requires that applications for new biological products contain data
that are adequate to assess the safety and effectiveness of the biological product for the claimed
indications in pediatric subpopulations, and to support dosing and administration information.
21 CFR 601.27(b); Reporting: provides that an applicant may request a deferred submission of
some or all assessments of safety and effectiveness required under 601.27(a) until after licensing
the product for use in adults.
21 CFR 601.27(c); Reporting: provides that an applicant may request a full or partial waiver of the
requirements under 601.27(a) with adequate justification.
21 CFR 601.28(a); Reporting: requires sponsors to submit to FDA a brief summary stating
whether labeling supplements for pediatric use have been submitted and whether new studies in the
pediatric population to support appropriate labeling for the pediatric population have been initiated.
21 CFR 601.28(b); Reporting: requires sponsors to submit to FDA an analysis of available safety
and efficacy data in the pediatric population and changes proposed in the labeling based on this
information.
21 CFR 601.28(c); Reporting: requires sponsors to submit to FDA a statement on the current
status of any postmarketing studies in the pediatric population performed by, on or behalf of, the
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applicant.
21 CFR 601.33, 601.34, 601.35; Reporting: clarifies the information required to be submitted in an
application to FDA to evaluate the safety and effectiveness of radiopharmaceuticals intended for in
vivo administration for diagnostic and monitoring use.
21 CFR 601.45; Reporting: requires applicants of biological products for serious or lifethreatening illnesses to submit to the Agency for consideration, during the pre-approval review
period, copies of all promotional materials, including promotional labeling as well as
advertisements.
21 CFR 601.70(b) and (d); Reporting: requires each applicant of a licensed biological product to
submit annually a report to FDA, accompanied by a completed transmittal Form FDA 2252
(Transmittal of Annual Report for Drugs and Biologics for Human Use), on the status of
postmarketing studies for each approved product application. Two copies of each annual report
must be submitted to FDA.
21 CFR 601.91(b)(3); Reporting: requires applicants to prepare and provide labeling with relevant
information to patient or potential patients for biological products approved under part 601, subpart
H when human efficacy studies are not ethical or feasible (or based on evidence of effectiveness
from studies conducted in animals).
21 CFR 601.94; Reporting: requires applicants under subpart H to submit to the Agency for
consideration during preapproval review period copies of all promotional materials including
promotional labeling as well as advertisements.
21 CFR 606.110(b); Reporting: requires the submission of a request for approval to perform
plasmapheresis of donors who do not meet certain donor requirements for the collection of plasma
containing rare antibodies.
21 CFR 610.9(a); Reporting: requires the applicant to present certain information in the form of a
license application or supplement to the application, for a modification of any particular test
method or manufacturing process or the conditions which it is conducted under the biologics
regulations.
21 CFR 610.15(d); Reporting: the Director of the Center for Biologics Evaluation and Research
(CBER) or the Director of the Center for Drug Evaluation and Research (CDER) may approve, as
appropriate, a manufacturer’s request for exceptions or alternatives to the regulation for constituent
materials. Manufacturers seeking approval of an exception or alternative must submit a request in
writing with a brief statement describing the basis for the request and the supporting data.
21 CFR 640.120; Reporting: requires licensed establishments to submit a request for an exception
or alternative to any requirement in the biologics regulations regarding blood, blood components,
or blood products.
21 CFR 680.1(c); Reporting: requires manufacturers to update annually their license file with the
list of source materials and the suppliers of the materials.

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21 CFR 680.1(b)(3)(iv); Reporting: requires manufacturers to notify FDA when certain diseases
are detected in source materials.
Amendments/ Resubmissions; Reporting: includes amendments to an unapproved application or
supplement or resubmission of a license application.
In addition to 21 CFR 601.2 and 601.12, other regulations in 21 CFR Parts 640, 660, and 680 relate
to information to be submitted in a license application or supplement for certain blood or allergenic
products: 21 CFR 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a)
and (b)(2), 660.51(a)(4), 680.1(b)(2)(iii), and (d). In table 1 of this document, the burden
associated with the information collection requirements in the applicable regulations is included in
the burden estimate for 21 CFR 601.2 and/or 601.12. A regulation may be listed under more than
one section of 21 CFR 601.12 due to the type of category under which a change to an approved
application may be submitted.
There are also additional container and/or package labeling requirements for certain licensed
biological products including: 21 CFR 640.74(b)(3) and (b)(4) for Source Plasma Liquid; 21 CFR
640.84(a) and (c) for Albumin; 21 CFR 640.94(a) for Plasma Protein Fraction; 21 CFR 660.2(c) for
Antibody to Hepatitis B Surface Antigen; 21 CFR 660.28(a), (b), and (c) for Blood Grouping
Reagent; 21 CFR 660.35(a), (c through g), and (i through m) for Reagent Red Blood Cells; 21 CFR
660.45 for Hepatitis B Surface Antigen; and 21 CFR 660.55(a) and (b) for Anti-Human Globulin.
The burden associated with the additional labeling requirements for submission of a license
application for these certain biological products is minimal because the majority of the burden is
associated with the requirements under 21 CFR 610.60 through 610.65 or 21 CFR 809.10. Section
601.91(b)(3) is also included under 21 CFR 610.60 through 610.65. Therefore, the burden
estimates for these regulations are included in the estimate under 21 CFR 610.60 through 610.65 in
table 1 of this document. The burden estimates associated with 21 CFR 809.10 are approved under
OMB control number control 0910-0485. In addition, the burden estimates associated with 21 CFR
610.67 are covered under OMB control number 0910-0537 and 0910-0116.
Under 21 CFR 601.2 and 601.12, the estimated hours per response are based on the average
number of hours to submit the various submissions. The estimated average number of hours is
based on the range of hours to complete a very basic application or supplement and a complex
application or supplement.
Under 21 CFR 601.6(a), the total annual responses are based on FDA estimates that establishments
may notify an average of 20 selling agents and distributors of such suspension, and provide FDA of
such notification. The number of respondents is based on the estimated annual number of
suspensions of a biologic license. In Table 1, FDA is estimating one in case a suspension occurs.
Under 21 CFR 601.12(f)(4) and 601.45, manufacturers of biological products may use Form FDA
2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use) to submit advertising and promotional labeling (which can include multiple pieces).
Under 21 CFR 601.28 and 601.70(b), FDA estimates that it takes an applicant approximately 24
hours (8 hours per study x 3 studies) annually to gather, complete, and submit the appropriate
information for each postmarketing status report (approximately 2 to 4 studies per report) and the
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accompanied transmittal Form FDA 2252. Included in these 24 hours is the time necessary to
prepare and submit two copies of the annual progress report of postmarketing studies to FDA under
21 CFR 601.70(d). Form FDA 2252 is approved under OMB control number 0910-0001.
Under 21 CFR 610.15(d), FDA has received no submissions since the implementation of the final
rule in April 2011. Therefore, FDA is estimating one respondent and one annual request to account
for a possible submission to CBER or CDER of a request for an exception or alternative for
constituent materials under 21 CFR 610.15(d).
Under 21 CFR 600.15(b), 601.53(d), 606.110(b), and 640.120, the burden estimate is included in
the estimate under 21 CFR 601.12(b).
Under 21 CFR 601.91(b)(2) and 601.93, any potential postmarketing reports and/or recordkeeping
burdens would be included under the adverse experience reporting (AER) requirements under 21
CFR Part 600. Therefore, any burdens associated with these requirements would be reported under
the AER information collection requirements (OMB control number 0910-0308).
Form FDA 356h “Application to Market a New or Abbreviated New Drug or Biologic for Human
Use,” is used for the applicable submissions to both CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain information to FDA and helps
to ensure that the application is complete and contains all the necessary information, so that delays
due to lack of information may be eliminated. In addition, the form provides key information to
FDA for efficient handling and distribution to the appropriate staff for review. FDA estimates an
average of 24 hours to complete the application form which in included in the average burden per
response. The estimate burden hours for nonbiological product submissions to CDER using FDA
Form 356h are approved under OMB control number 0910-0001.
The estimated burden hours for other product submissions to CDER using FDA Form 356h are
approved under OMB control number 0910-0001 (an estimated 3,200 submissions x 24 hours =
76,800 hours).
For advertisements and promotional labeling, (e.g., circulars, package labels, container labels, etc.)
and labeling changes, manufacturers of licensed biological products may submit to CBER or
CDER Form FDA 2253. Form FDA 2253 can also be submitted electronically. Form FDA 2253 is
approved under OMB control number 0910-0001.
12b. Annualized Cost Burden Estimate
Activity
Reporting
Reporting/Disclosure

Total Burden Hours

Hourly Wage Rate

Total Cost

439,899

$53

$23,314,647

11

$84

$924

The cost estimate is based on a regulatory affairs specialist, at a wage rate of $53/hour, who would
be responsible for filling out the form, and preparing an application, supplement, PMS report, or
other similar submission. The cost estimate is also based on a medical director at a wage rate of
$84/hour who would be responsible for preparing notification to FDA of discontinuance of a
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product(s) (3 hours), and notification to industry of a license suspension (1 notice of product
discontinuance (1 hour) and 21 notices of license suspension with an average of 20 minutes per
notification) (1 report to FDA and 20 notices of suspension to selling agents and distributors) (7
hours). The estimated average hourly pay rate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Record/keepers/Capital Costs
There are no capital costs or operating and maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
The estimated annualized cost to FDA is $18,936,855. This estimate is based on full-time
equivalents (FTEs) associated with the review of license applications including supplemental
applications or other similar submissions, and PMS reports. The amount of time and expense
incurred by the Federal government is due to the review of all material submitted with an
application, supplement, or other similar submission, and PMS reports. This information is
essential to determine the safety and effectiveness of products in support of FDA’s mission to
protect the public health. This information may include clinical data, safety updates, samples
submitted for evaluation by the agency, case report tabulations, case report forms, patient
information, and PMS. In addition, the estimate is based on the number of FTEs associated with
the processing of license revocations and suspensions, and advertising and promotional labeling.
The estimated average annual salary for CBER reviewers is $130,599 that includes benefits but no
overhead costs.
Activity
Application/Supplement
Review
License Processing
Advertisement/Promotional
Labeling
Review PMS Report

Number of
FTEs
103

Average Annual Reviewer Total Cost
Salary
$130,599
$13,451,697

36

$130,599

$4,701,564

5

$130,599

$652,995

1

$130,599

$130,599

Total

$18,936,855

15. Explanation for Program Changes or Adjustments
FDA’s estimated burden for the information collection reflects an overall increase of 105,867
hours and a decrease of 2,649 responses. FDA attributes this adjustment in the total hours to an
increase in the number of submissions we have received under 21 CFR 601.12(f)(4) and 601.45,
and 21 CFR 601.12(b)(1), (b)(3), and (e) over the last few years. FDA attributes the decrease in the
total annual response to a decrease in responses received under 21 CFR 601.12(a)(5) and 601.27(b)
over the last few years. While we have consolidated the IC elements as they appear at
www.reginfo.gov., we have retained the itemized burden table in Question 12 as included in our
Federal Register notices. We have also uploaded cost information included in our supporting
11

 

statement.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt the display of the expiration date of the OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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