[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42130-42131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3038]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Request for Samples 
and Protocols

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 19, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0206. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Request for Samples and Protocols

OMB Control Number 0910-0206--Extension

    This information collection supports Agency regulations. Under 
section 351 of the Public Health Service 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 the biologics licenses for such products 
are only issued when a product meets the prescribed standards. Under 
Sec.  610.2 (21 CFR 610.2), the Center for Biologics Evaluation and 
Research (CBER) or the Center for Drug Evaluation and Research 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 Sec.  610.2, there are other regulations that 
require the submission of samples and protocols for specific licensed 
biological products: 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).
    Section 660.6(a) provides requirements for the frequency of 
submission of samples from each lot of Antibody to Hepatitis B Surface 
Antigen product, and Sec.  660.6(b) provides the requirements for the 
submission of a protocol containing specific information along with 
each required sample. For Sec.  660.6 products subject to official 
release by CBER, one sample from each filling of each lot is required 
to be submitted along with a protocol consisting of a summary of the 
history of manufacture of the product, including all results of each 
test for which test results are requested by CBER. After official 
release is no longer required, one sample along with a protocol is 
required to be submitted at 90-day intervals. In addition, samples, 
which must be accompanied by a protocol, may at any time be required to 
be submitted to CBER if continued evaluation is deemed necessary.
    Section 660.36(a) requires, after each routine establishment 
inspection by FDA, the submission of samples from a lot of final 
Reagent Red Blood Cell product along with a protocol containing 
specific information. Section 660.36(a)(2) requires that a protocol 
contain information including, but not limited to, manufacturing 
records, certain test records, and identity test results. Section 
660.36(b) requires a copy of the antigenic constitution matrix 
specifying the antigens present or absent to be submitted to the CBER 
Director at the time of initial distribution of each lot.
    Section 660.46(a) contains requirements as to the frequency of 
submission of samples from each lot of Hepatitis B Surface Antigen 
product, and Sec.  660.46(b) contains the requirements as to the 
submission of a protocol containing specific information along with 
each required sample. For Sec.  660.46 products subject to official 
release by CBER, one sample from each filling of each lot is required 
to be submitted along with a protocol consisting of a summary of the 
history or manufacture of the product, including all results of each 
test for which test results are requested by CBER. After notification 
of official release is received, one sample along with a protocol is 
required to be submitted at 90-day intervals. In addition, samples, 
which must be accompanied by a protocol, may at any time be required to 
be submitted to CBER if continued evaluation is deemed necessary.
    Samples and protocols are required by FDA to help ensure the 
safety, purity, or potency of the 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 following burden estimate is for the protocols required to be 
submitted with each sample. The collection of samples is not a 
collection of information under 5 CFR 1320.3(h)(2). Respondents to the 
collection of information under Sec.  610.2 are manufacturers of 
licensed biological products. Respondents to the collection of 
information under Sec. Sec.  660.6(b), 660.36(a)(2) and (b), and 
660.46(b) are manufacturers of the specific products referenced 
previously in this document. 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 obtained from FDA's database system, approximately 79 
manufacturers submitted samples and

[[Page 42131]]

protocols in fiscal year (FY) 2017, under the regulations cited 
previously in this document. FDA estimates that approximately 75 
manufacturers submitted protocols under Sec.  610.2 and 2 manufacturers 
submitted protocols under the regulation (Sec.  660.6) for the other 
specific product. FDA received no submissions under Sec. Sec.  660.36 
or 660.46; however, FDA is using the estimate of one protocol 
submission under each regulation in the event that protocols are 
submitted in the future.
    The estimated total annual responses are based on FDA's final 
actions completed in FY 2017 for the various submission requirements of 
samples and protocols for the licensed biological products. The average 
burden per response is based on information provided by industry. The 
burden estimates provided by industry ranged from 1 to 5.5 hours. Under 
Sec.  610.2, the hours per response are 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 Sec.  610.2.
    In the Federal Register of May 11, 2018, (83 FR 22081), we 
published a notice soliciting public comment of the information 
collection. No comments were received.
    We therefore estimate the burden of the information collection as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
     21 CFR section/activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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610.2--Requests for Samples and               75          86.267           6,470               3          19,410
 Protocols; Official Release....
660.6(b)--Protocols.............               2             3.5               7               5              35
660.36(a)(2) and (b)--Samples                  1               1               1               6               6
 and Protocols..................
660.46(b)--Protocols............               1               1               1               5               5
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    Total.......................  ..............  ..............  ..............  ..............          19,456
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 764 hours and a corresponding increase of 262 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17859 Filed 8-17-18; 8:45 am]
 BILLING CODE 4164-01-P