[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16393-16395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0114]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Samples and Protocols
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 May 26, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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.
[[Page 16394]]
With respect to the following collection of information, FDA
invites comments on these topics: (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 21 CFR 610.2, the Center for Biologics Evaluation and Research
(CBER) or the Center for Drugs 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 FDA, 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 FDA, 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 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 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 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 80
manufacturers submitted samples and protocols in fiscal year (FY) 2014,
under the regulations cited previously in this document. FDA estimates
that approximately 76 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. 660.36 or Sec. 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 2014 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 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
Sec. 610.2. FDA estimates the burden of this information collection as
follows:
[[Page 16395]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR section Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
610.2 Lot Release Information Submission.... 76 84.54 6,197 3 18,591
660.6(b) Lot Release Information Submission. 2 9 18 5 90
660.36(a)(2) and (b) Lot Release Information 1 1 1 6 6
Submission.................................
660.46(b) Lot Release Information Submission 1 1 1 5 5
-------------------------------------------------------------------
Total................................... 80 .............. 6,217 ........... 18,692
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07008 Filed 3-26-15; 8:45 am]
BILLING CODE 4164-01-P