80 FR 57194 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Request for Samples and Protocols

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 183 (September 22, 2015)

Page Range		57194-57195
FR Document		2015-24028

The Food and Drug Administration (FDA) 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.

Federal Register, Volume 80 Issue 183 (Tuesday, September 22, 2015)

[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57194-57195]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0114]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) 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 October 
22, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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

    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

[[Page 57195]]

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.
    In the Federal Register of March 27, 2015 (80 FR 16393), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
610.2 Lot Release Information                 76           84.54           6,197               3          18,591
 Submission.....................
660.6(b) Lot Release Information               2            9                 18               5              90
 Submission.....................
660.36(a)(2) and (b) Lot Release               1            1                  1               6               6
 Information Submission.........
660.46(b) Lot Release                          1            1                  1               5               5
 Information Submission.........
                                 -------------------------------------------------------------------------------
    Total.......................              80  ..............           6,217  ..............          18,692
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24028 Filed 9-21-15; 8:45 am]
BILLING CODE 4164-01-P

57194 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices

ACTION: 60-Day notice of submission of clearance for qualitative information OMB control number 0910–0206. Also
information collection approval from will not be used for quantitative include the FDA docket number found
the Office of Management and Budget information collections that are in brackets in the heading of this
and request for comments. designed to yield reliably actionable document.
results, such as monitoring trends over
SUMMARY: As part of a Federal FOR FURTHER INFORMATION CONTACT: FDA
time or documenting program
Government-wide effort to streamline PRA Staff, Office of Operations, Food
performance. Such data uses require
the process to seek feedback from the and Drug Administration, 8455
more rigorous designs that address: the
public on service delivery, the Colesville Rd., COLE–14526, Silver
target population to which
Administration for Community Living Spring, MD 20993–0002,
generalizations will be made, the
proposes to submitted a Generic PRAStaff@fda.hhs.gov.
sampling frame, the sample design
Information Collection Request (Generic (including stratification and clustering), SUPPLEMENTARY INFORMATION: In
ICR): ‘‘Generic Clearance for the the precision requirements or power compliance with 44 U.S.C. 3507, FDA
Collection of Qualitative Feedback on calculations that justify the proposed has submitted the following proposed
Agency Service Delivery’’ to OMB for sample size, the expected response rate, collection of information to OMB for
approval under the Paperwork methods for assessing potential non- review and clearance.
Reduction Act (PRA) (44 U.S.C. 3501 et. response bias, the protocols for data
seq.). collection, and any testing procedures Request for Samples and Protocols—
DATES: Submit written or electronic that were or will be undertaken prior OMB Control Number 0910–0206—
comments on the collection of fielding the study. Depending on the Extension
information by November 23, 2015. degree of influence the results are likely Under section 351 of the Public
ADDRESSES: Submit electronic to have, such collections may still be Health Service Act (42 U.S.C. 262), FDA
comments on the collection of eligible for submission for other generic has the responsibility to issue
information to: Susan Jenkins at mechanisms that are designed to yield regulations that prescribe standards
Susan.Jenkins@aoa.hhs.gov. quantitative results. designed to ensure the safety, purity,
Submit written comments on the and potency of biological products and
Dated: September 17, 2015.
collection of information to to ensure that the biologics licenses for
Kathy Greenlee,
Administration for Community Living, such products are only issued when a
Washington, DC 20201, Attn. Susan Administrator and Assistant Secretary for
Aging. product meets the prescribed standards.
Jenkins. Under 21 CFR 610.2, the Center for
[FR Doc. 2015–24066 Filed 9–21–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT: Biologics Evaluation and Research
BILLING CODE 4154–01–P
Susan Jenkins at 202.357.3591. (CBER) or the Center for Drugs
SUPPLEMENTARY INFORMATION: Under the Evaluation and Research may at any
PRA (44 U.S.C. 3501–3520), Title: DEPARTMENT OF HEALTH AND time require manufacturers of licensed
Generic Clearance for the Collection of HUMAN SERVICES biological products to submit to FDA
Qualitative Feedback on Agency Service samples of any lot along with the
Delivery. Food and Drug Administration protocols showing the results of
Abstract: The information collection applicable tests prior to distributing the
[Docket No. FDA–2012–N–0114]
activity will garner qualitative customer lot of the product. In addition to § 610.2,
and stakeholder feedback in an efficient, Agency Information Collection there are other regulations that require
timely manner, in accordance with the Activities; Proposed Collection; the submission of samples and protocols
Administration’s commitment to Submission for Office of Management for specific licensed biological products:
improving service delivery. By and Budget Review; Request for 21 CFR 660.6 (Antibody to Hepatitis B
qualitative feedback we mean Samples and Protocols Surface Antigen); 21 CFR 660.36
information that provides useful (Reagent Red Blood Cells); and 21 CFR
insights on perceptions and opinions, AGENCY: Food and Drug Administration, 660.46 (Hepatitis B Surface Antigen).
but are not statistical surveys that yield HHS. Section 660.6(a) provides
quantitative results that can be ACTION: Notice. requirements for the frequency of
generalized to the population of study. submission of samples from each lot of
This feedback will provide insights into SUMMARY: The Food and Drug Antibody to Hepatitis B Surface Antigen
customer or stakeholder perceptions, Administration (FDA) is announcing product, and § 660.6(b) provides the
experiences and expectations, provide that a proposed collection of requirements for the submission of a
an early warning of issues with service, information has been submitted to the protocol containing specific information
or focus attention on areas where Office of Management and Budget along with each required sample. For
communication, training or changes in (OMB) for review and clearance under § 660.6 products subject to official
operations might improve delivery of the Paperwork Reduction Act of 1995. release by FDA, one sample from each
products or services. These collections DATES: Fax written comments on the filling of each lot is required to be
will allow for ongoing, collaborative and collection of information by October 22, submitted along with a protocol
actionable communications between the 2015. consisting of a summary of the history
Agency and its customers and ADDRESSES: To ensure that comments on of manufacture of the product,
stakeholders. It will also allow feedback the information collection are received, including all results of each test for
tkelley on DSK3SPTVN1PROD with NOTICES

to contribute directly to the OMB recommends that written which test results are requested by
improvement of program management. comments be faxed to the Office of CBER. After official release is no longer
Feedback collected under this generic Information and Regulatory Affairs, required, one sample along with a
clearance will provide useful OMB, Attn: FDA Desk Officer, FAX: protocol is required to be submitted at
information, but it will not yield data 202–395–7285, or emailed to 90-day intervals. In addition, samples,
that can be generalized to the overall oira_submission@omb.eop.gov. All which must be accompanied by a
population. This type of generic comments should be identified with the protocol, may at any time be required to

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Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices 57195

be submitted to CBER if continued CBER if continued evaluation is deemed manufacturers submitted samples and
evaluation is deemed necessary. necessary. protocols in fiscal year (FY) 2014, under
Section 660.36(a) requires, after each Samples and protocols are required by the regulations cited previously in this
routine establishment inspection by FDA to help ensure the safety, purity, or document. FDA estimates that
FDA, the submission of samples from a potency of a product because of the approximately 76 manufacturers
lot of final Reagent Red Blood Cell potential lot-to-lot variability of a submitted protocols under § 610.2 and 2
product along with a protocol product produced from living manufacturers submitted protocols
containing specific information. Section organisms. In cases of certain biological under the regulation (§ 660.6) for the
660.36(a)(2) requires that a protocol products (e.g., Albumin, Plasma Protein other specific product. FDA received no
contain information including, but not Fraction, and therapeutic biological submissions under § 660.36 or § 660.46,
limited to, manufacturing records, products) that are known to have lot-to- however FDA is using the estimate of
certain test records, and identity test lot consistency, official lot release is not one protocol submission under each
results. Section 660.36(b) requires a normally required. However, regulation in the event that protocols are
copy of the antigenic constitution submissions of samples and protocols of submitted in the future.
matrix specifying the antigens present these products may still be required for In the Federal Register of March 27,
surveillance, licensing, and export 2015 (80 FR 16393), FDA published a
or absent to be submitted to the CBER
purposes, or in the event that FDA
Director at the time of initial 60-day notice requesting public
obtains information that the
distribution of each lot. comment on the proposed collection of
manufacturing process may not result in
Section 660.46(a) contains information. No comments were
consistent quality of the product.
requirements as to the frequency of The following burden estimate is for received.
submission of samples from each lot of the protocols required to be submitted The estimated total annual responses
Hepatitis B Surface Antigen product, with each sample. The collection of are based on FDA’s final actions
and § 660.46(b) contains the samples is not a collection of completed in FY 2014 for the various
requirements as to the submission of a information under 5 CFR 1320.3(h)(2). submission requirements of samples
protocol containing specific information Respondents to the collection of and protocols for the licensed biological
along with each required sample. For information under § 610.2 are products. The average burden per
§ 660.46 products subject to official manufacturers of licensed biological response is based on information
release by FDA, one sample from each products. Respondents to the collection provided by industry. The burden
filling of each lot is required to be of information under §§ 660.6(b), estimates provided by industry ranged
submitted along with a protocol 660.36(a)(2) and (b), and 660.46(b) are from 1 to 5.5 hours. Under § 610.2, the
consisting of a summary of the history manufacturers of the specific products average burden per response is based on
of manufacture of the product, referenced previously in this document. the average of these estimates and
including all results of each test for The estimated number of respondents rounded to 3 hours. Under the
which test results are requested by for each regulation is based on the remaining regulations, the average
CBER. After notification of official annual number of manufacturers that burden per response is based on the
release is received, one sample along submitted samples and protocols for higher end of the estimate (rounded to
with a protocol is required to be biological products including 5 or 6 hours) since more information is
submitted at 90-day intervals. In submissions for lot release, surveillance, generally required to be submitted in
addition, samples, which must be licensing, or export. Based on the other protocols than under § 610.2.
accompanied by a protocol, may at any information obtained from FDA’s FDA estimates the burden of this
time be required to be submitted to database system, approximately 80 information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent 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 Submission 1 1 1 6 6
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: September 16, 2015. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
Leslie Kux, HUMAN SERVICES hereby given of the following meeting.
Associate Commissioner for Policy. The meeting will be closed to the
[FR Doc. 2015–24028 Filed 9–21–15; 8:45 am] National Institutes of Health public in accordance with the
provisions set forth in section 552b(c)(4)
BILLING CODE 4164–01–P
tkelley on DSK3SPTVN1PROD with NOTICES

Eunice Kennedy Shriver National and 552b(c)(6), Title 5 U.S.C., as
Institute of Child Health and Human amended. The grant applications and
Development; Notice of Closed the discussions could disclose
Meeting confidential trade secrets or commercial
property such as patentable material,
Pursuant to section 10(d) of the and personal information concerning
Federal Advisory Committee Act, as individuals associated with the grant

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Document Created: 2015-12-15 09:35:08
Document Modified: 2015-12-15 09:35:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by October 22, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PR[email protected]
FR Citation		80 FR 57194

80 FR 57194 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Request for Samples and Protocols

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 183 (September 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration