Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols, 41488-41490 [2021-16384]
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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
studies or resulted in the production of
the drugs affected by the fraud’’ and that
‘‘[t]he drugs produced were free of fraud
and material false statements.’’ Ms. Ngo
then asserts that her lack of financial
motive for conducting her offense
weighs in her favor because ‘‘the
maximum period of debarment should
be reserved for those who profit.’’
In determining the period of Ms.
Ngo’s debarment, whether she could
have been convicted of a felony is not
relevant. Under section 306(c)(3) of the
FD&C act, FDA considers the nature and
seriousness of the offense. Ms. Ngo
admitted to knowingly and repeatedly
falsifying clinical trial records.
Additionally, the inclusion of a
provision in Ms. Ngo’s plea agreement
that prevents her from engaging in
clinical research ‘‘during any term of
probation or supervised release’’ evinces
concern by the prosecution that she
would continue to violate the law if
involved in clinical research.
As set forth in the proposal to debar,
‘‘[t]he creation and submission of
falsified clinical trial data undermines
FDA’s determination of safety,
effectiveness, and quality of the drugs
the studies were designed to assess.’’
Although the scope of conduct to which
Ms. Ngo admitted during the criminal
proceedings may have been limited to a
few patients, submitting any false or
fabricated data to the FDA is a serious
offense that compromises the public
health. Further, it is irrelevant that Eli
Lilly ultimately did not use any of her
information ‘‘in a detrimental way.’’
Had Ms. Ngo’s conduct gone undetected
and Eli Lilly submitted a new drug
application containing the falsified data,
FDA might have relied on her fabricated
information to approve a new drug
product, which reliance could have
compromised the public health.
Additionally, Ms. Ngo’s lack of financial
gain from her conduct does not
diminish the nature and seriousness of
her offense. Accordingly, Ms. Ngo has
failed to create a genuine and material
factual dispute with respect to the
nature and seriousness of her offense.
Ms. Ngo next argues that, because she
has not been involved in clinical trials
since entering her guilty plea, there are
‘‘reasonable assurances’’ that ‘‘the
offense will not happen again.’’ Ms. Ngo
appears to be referencing the
consideration under section 306(c)(3)(D)
of the FD&C Act, where FDA must
consider, where applicable, ‘‘whether
the extent to which changes in
ownership, management, or operations
have corrected the causes of any offense
involved and provide reasonable
assurances that the offense will not
occur in the future.’’ The considerations
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Jkt 253001
in section 306(c)(3) of the FD&C Act are
not only for individuals but also for
corporations, partnerships, and
associations subject to permissive
debarment. The consideration at issue
does not typically apply to individuals
because individuals are incapable of
changes in ownership or management
and could only alter the current
operations of a business enterprise in
which they are currently engaged. Even
assuming for the sake of argument that
an individual could point to changes in
his or her current business practices as
an applicable consideration under
section 306(c)(3) of the FD&C Act, Ms.
Ngo offers no actual facts to support her
assertion that there are reasonable
assurances that the offense will not
occur again in the future; therefore, her
unsubstantiated contention that,
because she has not been involved in
clinical trials since entering her guilty
plea provides reasonable assurances that
she will not commit the offense again,
fails to create a genuine and substantial
issue of fact that warrants a hearing.
Finally, Ms. Ngo argues that the
maximum period of debarment is
inappropriate for first-time offenders.
While the Agency does consider prior
convictions involving matters within
the FDA’s jurisdiction under section
306(c)(3)(F) of the FD&C Act, that
consideration is only one of several that
FDA considers in determining the
appropriateness and period of
debarment under section 306(c)(3). Ms.
Ngo knowingly and repeatedly falsified
clinical data records. FDA has
determined that the conduct underlying
her offense, combined with her failure
to take any voluntary steps to mitigate
the effect of her offense on the public,
is sufficiently serious to warrant a 5year period of debarment, even though
she does not have any prior convictions
involving matters within the Agency’s
jurisdiction.
Fmt 4703
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[FR Doc. 2021–16352 Filed 7–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2002–N–0314]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Request for
Samples and Protocols
AGENCY:
ACTION:
Therefore, the Chief Scientist, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act and under the authority delegated to
her by the Commissioner of Food and
Drugs, finds: (1) That Ms. Ngo has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval of a drug
product or otherwise relating to the
regulation of a drug product under the
FD&C Act and (2) that the conduct
underlying the conviction undermines
the process for the regulation of drugs.
FDA has considered the relevant factors
listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of
5 years is appropriate.
Frm 00056
Dated: July 27, 2021.
Denise Hinton,
Chief Scientist.
Food and Drug Administration,
HHS.
III. Findings and Order
PO 00000
As a result of the foregoing findings,
Ms. Ngo is debarred for 5 years from
providing services in any capacity to a
person with an approved or pending
drug product application under section
505, 512, or 802 of the FD&C Act (21
U.S.C. 335, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective August 2,
2021 (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or
pending drug product application, who
knowingly uses the services of Ms. Ngo,
in any capacity during her period of
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
Ngo, during her period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application, that person
will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Ms. Ngo during her period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Notice.
The Food and Drug
Administration (FDA 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: Submit written comments
(including recommendations) on the
collection of information by September
1, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0206. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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:
Request for Samples and Protocols
khammond on DSKJM1Z7X2PROD with NOTICES
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: §§ 660.6, 660.36, and 660.46
(21 CFR 660.6, 660.36, and 660.46).
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
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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 § 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.
PO 00000
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41489
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 75
manufacturers submitted samples and
protocols in fiscal year (FY) 2020 under
the regulations cited previously in this
document. FDA estimates that
approximately 72 manufacturers
submitted protocols under § 610.2, and
3 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.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2020 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 hour 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
regulations, the average burden per
response is based on the higher end of
the estimate (rounded to 5 or 6 hours)
because more information is generally
required to be submitted in the other
protocols than under § 610.2.
In the Federal Register of March 16,
2021 (86 FR 14448), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\02AUN1.SGM
02AUN1
41490
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
Total annual
responses
Average
burden per
response
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 .............................................................
72
3
1
1
82.972
4
1
1
5,974
12
1
1
3
5
6
5
17,922
60
6
5
Total ..............................................................................
77
........................
5,988
........................
17,993
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 decrease of 1,463 hours and a
corresponding decrease of 491
responses. We attribute this adjustment
to a decrease in the number of
submissions we received over the last
few years.
Dated: July 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16384 Filed 7–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: In
accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing
all currently HHS-certified laboratories
SUMMARY:
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Number of
responses per
respondent
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17:21 Jul 30, 2021
Jkt 253001
and IITFs is published in the Federal
Register during the first week of each
month. If any laboratory or IITF
certification is suspended or revoked,
the laboratory or IITF will be omitted
from subsequent lists until such time as
it is restored to full certification under
the Mandatory Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
of the laboratories currently certified to
meet the standards of the Mandatory
Guidelines using Oral Fluid.
The Mandatory Guidelines using
Urine were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in
the Federal Register on June 9, 1994 (59
FR 29908); September 30, 1997 (62 FR
51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858);
December 10, 2008 (73 FR 75122); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral
Fluid were first published in the
Federal Register on October 25, 2019
(84 FR 57554) with an effective date of
January 1, 2020.
The Mandatory Guidelines were
initially developed in accordance with
Executive Order 12564 and section 503
of Pubic Law 100–71 and allowed urine
drug testing only. The Mandatory
Guidelines using Urine have since been
revised, and new Mandatory Guidelines
allowing for oral fluid drug testing have
been published. The Mandatory
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Guidelines require strict standards that
laboratories and IITFs must meet in
order to conduct drug and specimen
validity tests on specimens for federal
agencies. HHS does not allow IITFs to
conduct oral fluid testing.
To become certified, an applicant
laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITFs in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines using Urine and/
or Oral Fluid. An HHS-certified
laboratory or IITF must have its letter of
certification from HHS/SAMHSA
(formerly: HHS/NIDA), which attests
that the test facility has met minimum
standards. HHS does not allow IITFs to
conduct oral fluid testing.
HHS-Certified Laboratories Approved
To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory
Guidelines using Oral Fluid dated
October 25, 2019 (84 FR 57554), the
following HHS-certified laboratories
meet the minimum standards to conduct
drug and specimen validity tests on oral
fluid specimens: At this time, there are
no laboratories certified to conduct drug
and specimen validity tests on oral fluid
specimens.
HHS-Certified Instrumented Initial
Testing Facilities Approved To Conduct
Urine Drug Testing
In accordance with the Mandatory
Guidelines using Urine dated January
23, 2017 (82 FR 7920), the following
HHS-certified IITFs meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
Dynacare, 6628 50th Street NW,
Edmonton, AB Canada T6B 2N7, 780–
784–1190 (Formerly: GammaDynacare Medical Laboratories)
E:\FR\FM\02AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41488-41490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16384]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2002-N-0314]
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 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: Submit written comments (including recommendations) on the
collection of information by September 1, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain.
[[Page 41489]]
Find this particular information collection by selecting ``Currently
under Review--Open for Public Comments'' or by using the search
function. The OMB control number for this information collection is
0910-0206. Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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: Sec. Sec. 660.6, 660.36, and 660.46 (21 CFR
660.6, 660.36, and 660.46).
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 75
manufacturers submitted samples and protocols in fiscal year (FY) 2020
under the regulations cited previously in this document. FDA estimates
that approximately 72 manufacturers submitted protocols under Sec.
610.2, and 3 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 2020 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 hour 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) because more information is
generally required to be submitted in the other protocols than under
Sec. 610.2.
In the Federal Register of March 16, 2021 (86 FR 14448), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 41490]]
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 72 82.972 5,974 3 17,922
Protocols; Official Release....
660.6(b), Protocols............. 3 4 12 5 60
660.36(a)(2) and (b), Samples 1 1 1 6 6
and Protocols..................
660.46(b), Protocols............ 1 1 1 5 5
-------------------------------------------------------------------------------
Total....................... 77 .............. 5,988 .............. 17,993
----------------------------------------------------------------------------------------------------------------
\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 decrease of 1,463 hours and a corresponding decrease of 491
responses. We attribute this adjustment to a decrease in the number of
submissions we received over the last few years.
Dated: July 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16384 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P
