[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22081-22083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10052]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1565]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection requirements 
relating to the regulations which state that protocols for samples of 
biological products must be submitted to the Agency.

DATES: Submit either electronic or written comments on the collection 
of information by July 10, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 10, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-1565 for ``Request for Samples

[[Page 22082]]

and Protocols.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Request for Samples and Protocols

OMB Control Number 0910-0206--Extension

    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); 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

[[Page 22083]]

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 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 two 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. FDA 
estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     21 CFR section/activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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.......................              79  ..............           6,479  ..............          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: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10052 Filed 5-10-18; 8:45 am]
 BILLING CODE 4164-01-P


