0206 CBER samples and protocols SSA 2018

United States Food and Drug Administration
Request for Samples and Protocols
OMB Control No. 0910-0206
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations.
Under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), FDA has the
responsibility to issue regulations that prescribe standards designed to ensure the safety, purity, and
potency of biological products and to ensure that biologics licenses for such products are only issued
when a product meets the prescribed standards. Under 21 CFR 610.2, FDA’s Centers for Biologics
Evaluation and Research (CBER) and Drug Evaluation and Research (CDER) may, at any time,
require manufacturers of licensed biological products to submit to FDA samples of any lot along with
the protocols showing the results of applicable tests prior to distributing the lot of the product. In
addition to 21 CFR 610.2, other regulations also require the submission of samples and protocols for
specific licensed biological products; specifically 21 CFR 660.6 – Antibody to Hepatitis B Surface
Antigen; 21 CFR 660.36 – Reagent Red Blood Cells; and 21 CFR 660.46 – Hepatitis B Surface
Antigen.
Accordingly, we request extension of OMB approval for the information collection provisions
associated with the applicable regulations and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Samples and protocols are required by FDA to help ensure the safety, purity, and potency of a
product because of the potential lot-to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein Fraction, and therapeutic
biological products) that are known to have lot-to-lot consistency, official lot release is not normally
required. However, submissions of samples and protocols of these products may still be required for
surveillance, licensing, and export purposes, or in the event that FDA obtains information that the
manufacturing process may not result in consistent quality of the product. The written protocols are
reviewed by FDA scientists and other staff with expertise in the appropriate product and scientific
area. FDA tests samples to verify the manufacturer’s test results. A manufacturer may not distribute
a product until FDA gives the official release for the lot.
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. FDA accepts electronic lot release protocols and has issued guidance to assist
manufacturers in this area. FDA believes that the increased use of computer-assisted protocol
submissions will enhance the timeliness, effectiveness, and efficiency of the review process and
reduce burdensome, nonessential hard-copy handling and storage.

We are not aware of any other improved technology to reduce the burden. We continue to pursue
methods of applying technology to reduce the burden to the respondents of the information
collection.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Regulations applicable the submission of
samples and protocols for biological products for the purposes of lot release surveillance, licensing,
or export is the responsibility of FDA.
5. Impact on Small Businesses or Other Small Entities
There are no exemptions to the regulatory requirements, however we do not believe this imposes
undue burden on small entities. Although the statutory and regulatory requirements apply equally to
all enterprises, CBER’s Office of Communication, Outreach, and Development, Division of
Manufacturer’s Assistance and Training, and CDER’s Office of Communication, Division of Drug
Information and International and Consumer Assistance provide assistance to small businesses
subject to FDA’s regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with applicable statutory and regulatory
requirements and enables us to properly evaluate results of specific tests identified for lot release
review in the license application. Less frequent collection may pose unnecessary risk to the public
health. We are unware of any 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 protocol. FDA protects confidential information received from
manufacturers to the extent permitted by law. In addition, the frequency of submissions may be more
often than quarterly depending on the number of lots produced for a product over that time.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice in the Federal Register on May
11, 2018 (83 FR 22081), soliciting public comment on the information collection provisions. No
comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of Information
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Act (FOIA) and FDA’s published regulations under “Public Information” (21 CFR Part 20).
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The total annual estimated burden for this collection of information is 19,456 hours.
Table 1 -- Estimated Annual Reporting Burden1
21 CFR Section

610.2; Requests for
samples and protocols;
official release.
660.6; Samples;
protocols; official release.
660.36; Samples and
protocols.
660.46; Samples;
protocols; official release.
Total
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No. of
Respondents

No. of
Responses per
Respondent

Total Annual
Responses

Avg.
Burden per
Response

Total
Hours

75

86.267

6,470

3

19,410

2

3.5

7

5

35

1

1

1

6

6

1

1

1

5

5

79

6,479

19,456

There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate is for burden attributable to protocols required to be submitted with each sample.
The samples are not defined as information collection under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under 21 CFR 610.2 are manufacturers of licensed biological products.
Respondents to the collection of information under 21 CFR 660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products under these regulations. The estimated number
of respondents for each regulation is based on the annual number of manufacturers that submitted
samples and protocols for biological products, including submissions for lot release, surveillance,
licensing, or export. Based on information recorded in our databases, approximately 79
manufacturers submitted samples and protocols in fiscal year (FY) 2017 under the regulations cited
above. We estimate that 75 manufacturers submitted protocols under § 610.2, and 2 manufacturers
submitted protocols under the regulation (§ 660.6) for the specific product. No submissions have
been received under 21 CFR 660.36 and 660.46, however we retain a placeholder of one in the event
of future submissions.
The estimated number of annual responses is based on FDA’s final actions completed in FY 2017 for
the various submission requirements of samples and protocols for licensed biological products. The
average burden per response is based on informal communications with industry. The burden
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estimates provided by industry ranged from 1 to 5.5 hours. Under 21 CFR 610.2, the average burden
per response is based on the average of these estimates and rounded to 3 hours. Under the remaining
regulations, the average burden per response is based on the higher end of the estimate (rounded to 5
or 6 hours) since more information is generally required to be submitted in the other protocols than
under § 610.2.
12b. Annualized Cost Burden Estimate
The estimated annual cost to respondents is $1,381,376.00.
Activity

Total Burden Hours

Hourly Wage Rate

Reporting

19,456

$71

Total Respondent
Costs
$1,381,376

The cost estimate is based on an average pay rate of $71.00/hour. This average is based on the
salaries of an upper-level manager, a mid-level professional, and clerical support that may be
involved in the preparation and submission of the protocol.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/ Capital Costs
There are no capital, operating or maintenance costs associated with this collection of information.
14. Annualized Cost to Federal Government
The estimated annualized cost to FDA is $1,010,724.00. The review of each protocol by FDA
involves six persons, at an average pay rate of $52.00/hour, who spend approximately 3 hours per
protocol. The estimate is based on FDA’s final actions completed in FY 2017, which totaled 6,479.
This estimate does not include the time related to the testing of samples, because the submission of
samples is not a collection of information as defined under the PRA.
Activity
Protocol Review

Number of
Reviews
6,479

Review Time
3 hrs.

Average Cost
per Hour
$52

Total Cost
$1,010,724

15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. Specifically we have increased the number of
annual responses by 262 consistent with submissions received by FDA. This results in a
correspondeing increase to the number of annual burden hours by 764. We attribute the adjustment
to an increase in the number of submissions received over the last few years.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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