Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols, 42130-42131 [2018-17859]
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42130
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
The burden for this information
collection has changed since the last
OMB approval. Our burden estimate
reflects a decrease in burden by 14
records and 112 hours. We attribute this
adjustment to a decrease in the number
of requests received over the last few
years.
Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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 oira_
submission@omb.eop.gov. 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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
daltland on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:04 Aug 17, 2018
Jkt 244001
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 § 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
§ 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 § 660.6(b) provides the
requirements for the submission of a
protocol containing specific information
along with each required sample. For
§ 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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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 § 660.46(b) contains the
requirements as to the submission of a
protocol containing specific information
along with each required sample. For
§ 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-tolot 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 § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 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
E:\FR\FM\20AUN1.SGM
20AUN1
42131
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
protocols in fiscal year (FY) 2017, under
the regulations cited previously in this
document. FDA estimates that
approximately 75 manufacturers
submitted protocols under § 610.2 and 2
manufacturers submitted protocols
under the regulation (§ 660.6) for the
other specific product. FDA received no
submissions under §§ 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.
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.
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:
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 § 610.2, the
hours per response are based on the
average of these estimates and rounded
to 3 hours. Under the remaining
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section/activity
Average
burden per
response
Total annual
responses
Total hours
610.2—Requests for Samples and Protocols; Official Release .................................................................................
660.6(b)—Protocols .............................................................
660.36(a)(2) and (b)—Samples and Protocols ....................
660.46(b)—Protocols ...........................................................
75
2
1
1
86.267
3.5
1
1
6,470
7
1
1
3
5
6
5
19,410
35
6
5
Total ..............................................................................
........................
........................
........................
........................
19,456
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
ADDRESSES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
SUPPLEMENTARY INFORMATION:
[Document Identifier: OS–0990–0438]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS
Notice.
AGENCY:
ACTION:
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 19,
2018.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Office of
Adolescent Health Teen Pregnancy
Prevention, FY 2015–2020 Performance
Measure Collection.
Type of Collection: Extension.
OMB No. 0990–0438.
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS), is
requesting renewal by OMB of the
existing information collection request
for performance measures collection
from the TPP grant recipients.
Performance measure data collection is
a requirement of TPP grants; the
extension will allow for the completion
of data collection from cohort 2. The
collection will provide OAH with
performance data to inform planning
decisions; identify technical assistance
needs for grantees; facilitate grantees’
continuous quality improvement in
program implementation; and provide
HHS, Congress, OMB, and the general
public with information about the
individuals who participate in TPPfunded activities.
daltland on DSKBBV9HB2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Grant Recipient—Dissemination Form ......................................................
Grant Recipient—Partnerships Form ........................................................
VerDate Sep<11>2014
19:04 Aug 17, 2018
Jkt 244001
PO 00000
Frm 00032
Fmt 4703
Number of
responses per
respondent
84
84
Sfmt 4703
E:\FR\FM\20AUN1.SGM
Average
burden
per response
(in hours)
2
2
20AUN1
15/60
15/60
Total burden
hours
42
42
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 19,456
----------------------------------------------------------------------------------------------------------------
\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
