Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 18652-18654 [2017-07965]
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18652
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–07963 Filed 4–19–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by May 22,
2017.
DATES:
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 0910–0606. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
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
17:27 Apr 19, 2017
Jkt 241001
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements—21 CFR Part 111; OMB
Control Number 0910–0606—Extension
On October 25, 1994, the Dietary
Supplement Health and Education Act
(DSHEA) (Pub. L. 103–417) was signed
into law. DSHEA, among other things,
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding
section 402(g) of the FD&C Act (21
U.S.C. 342(g)). Section 402(g)(2) of the
FD&C Act provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practices for dietary
supplements. Section 402(g) of the
FD&C Act also stipulates that such
regulations will be modeled after
current good manufacturing practice
(CGMP) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. Section
402(g)(1) of the FD&C Act states that a
dietary supplement is adulterated if ‘‘it
has been prepared, packed, or held
under conditions that do not meet
current good manufacturing practice
regulations.’’ Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may
issue regulations necessary for the
efficient enforcement of the FD&C Act.
In the Federal Register of June 25, 2007
(72 FR 34752), (the June 25, 2007, final
rule), FDA published a final rule that
established, in part 111 (21 CFR part
111), the minimum CGMP necessary for
activities related to manufacturing,
packaging, labeling, or holding dietary
supplements to ensure the quality of the
dietary supplement.
Records are an indispensable
component of CGMP. The records
required by FDA’s regulations in part
111 provide the foundation for the
planning, control, and improvement
processes that constitute a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMP. The
records show what is to be
manufactured; what was, in fact,
manufactured; and whether the controls
that the manufacturer put in place to
ensure the identity, purity, strength, and
composition and limits on contaminants
and to prevent adulteration were
effective. Further, records will show
whether and what deviations from
control processes occurred, facilitate
evaluation and corrective action
concerning these deviations (including,
where necessary, whether associated
batches of product should be recalled
from the marketplace), and enable a
manufacturer to assure that the
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
corrective action was effective. In
addition, by establishing recordkeeping
requirements, FDA can ensure that
industry follows CGMP during
manufacturing, packaging, labeling, or
holding operations. The regulations in
part 111 establish the minimum
manufacturing practices necessary to
ensure that dietary supplements are
manufactured, packaged, labeled, or
held in a manner that will ensure the
quality of the dietary supplements
during manufacturing, packaging,
labeling or holding operations.
The recordkeeping requirements of
the regulations include establishing
written procedures and maintaining
records pertaining to: (1) Personnel; (2)
sanitation; (3) calibration of instruments
and controls; (4) calibration, inspection,
or checks of automated, mechanical, or
electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and
utensils and other contact surfaces; (6)
water used that may become a
component of the dietary supplement;
(7) production and process controls; (8)
quality control; (9) components,
packaging, labels and product received
for packaging and labeling; (10) master
manufacturing and batch production;
(11) laboratory operations; (12)
manufacturing operations; (13)
packaging and labeling operations; (14)
holding and distributing operations; (15)
returned dietary supplements; and (16)
product complaints.
Description of Respondents:
Manufacturers, dietary supplement
manufacturers, packagers and
repackagers, labelers and re-labelers,
holders, distributors, warehousers,
exporters, importers, large businesses,
and small businesses engaged in the
dietary supplement industry.
The recordkeeping requirements of
the regulations in part 111 are set forth
in each subpart. In table 1, we list the
annual burdens associated with
recordkeeping, as described in the June
25, 2007, final rule. For some provisions
listed in table 1, we did not estimate the
number of records per recordkeeper
because recordkeeping occasions consist
of frequent brief entries of dates,
temperatures, monitoring results, or
documentation that specific actions
were taken. Information might be
recorded a few times a day, week, or
month. When the records burden
involves frequent brief entries, we
entered 1 as the default for the number
of records per recordkeeper. For
example, many of the records listed
under § 111.35 in table 1, such as
§ 111.35(b)(2) (documentation, in
individual equipment logs, of the date
of the use, maintenance, cleaning, and
sanitizing of equipment), involve many
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
short sporadic entries over the course of
the year, varying across equipment and
plants in the industry. We did not
attempt to estimate the actual number of
recordkeeping occasions for these
provisions, but instead entered an
estimate of the average number of hours
per year. We entered the default value
of 1 as the number of records per
recordkeeper for these and similar
provisions. For § 111.35, the entry for
number of records is 1 as a default
representing a large number of brief
recordkeeping occasions.
In many rows of table 1, we list a
burden under a single provision that
covers the written procedures or records
described in several provisions. For
example, the burden of the batch
production records listed in table 1
under § 111.260 includes the burden for
records listed under § 111.255 because
the batch production records must
include those records.
The number of records for batch
production records (and other records
kept on a batch basis in table 1) equals
the annual number of batches. The
estimated burden for records kept by
batch includes both records kept for
every batch and records kept for some
but not all batches. We use the annual
number of batches as the number of
records that will not necessarily be kept
for every batch, such as test results or
material review and disposition records,
because such records are part of records,
if they are necessary, that will be kept
for every batch.
In the Federal Register of September
29, 2016 (81 FR 66967), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received comments
from two commenters.
(Comment 1) One commenter had
concerns about whether the processes
being used to assess the contents of
supplements are genuine and accurate
and how this is regulated; whether
records regarding labeling indicate what
is actually contained in a supplement;
and whether these records will be
available to the public.
These comments appear to address
PRA issues of practical utility and ways
to enhance the quality, utility, and
clarity of the information to be
collected.
(Response 1) In this collection of
information, FDA is evaluating the
burden of retaining records and making
them available to regulatory officials,
but not the burden for proactively
submitting them to FDA. FDA reviews
the records maintained while
conducting an investigation (e.g., during
a facility inspection and during the
followup communication until a
particular investigation is closed out).
The investigation of a particular firm by
FDA is exempt from the PRA and is not
included as part of the burden estimate.
The required elements of labeling are
part of different regulations and do not
apply to this collection of information.
The commenter also discussed the
safety of a particular product but CGMP
regulations deal with establishing a
18653
quality product, not necessarily a safe
product. Finally, the commenter
discussed allowing the records
maintained to be made public. These
records are required to be maintained by
the firm and are not proactively
submitted to FDA, but they are required
to be made available to FDA during
inspections. If FDA obtains these
records during the investigation of a
firm, the public can submit a Freedom
of Information Act request but the
document they would typically receive
would be redacted because the records
are the property of the firm.
(Comment 2) The second commenter
stated that the labeling on dietary
supplement products should be
consistent and FDA regulated, the term
‘‘healthy’’ should be required to have a
standard meaning, and ‘‘healthy’’
should not be allowed to be used unless
it meets FDA requirements of the term.
(Response 2) The recordkeeping for
CGMPs has nothing to do with the
required elements of food and dietary
supplement labeling, which are covered
under FDA’s labeling regulations. FDA
recently published, on May 27, 2016, a
final rule for Nutrition (and
Supplement) Facts Labels (81 FR
33741), and is currently reviewing new
requirements for labeling your food
‘‘healthy’’. This information collection
for CGMP addresses recordkeeping for
specifications for a label and labeling
operations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
asabaliauskas on DSK3SPTVN1PROD with NOTICES
21 CFR section
111.14, Records of personnel practices, including
documentation of training.
111.23, Records of physical plant sanitation practices, including pest control and water quality.
111.35, Records of equipment and utensils calibration and sanitation practices.
111.95, Records of production and process control
systems.
111.140, Records that quality control personnel must
make and keep.
111.180, Records associated with components, packaging, labels, and product received for packaging
and labeling as a dietary supplement.
111.210, Requirements for what the master manufacturing record must include.
111.260, Requirements for what the batch record
must include.
111.325, Records that quality control personnel must
make and keep for laboratory operations.
111.375, Records of the written procedures established for manufacturing operations.
111.430, Records of the written procedures for packaging and labeling operations.
111.475, Records of product distribution and procedures for holding and distributing operations.
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
PO 00000
Number of
records per
recordkeeper
Total
annual
records
Average burden per
recordkeeping
Total
hours
15,000
60,000
1 .............................
60,000
15,000
1
15,000
0.2 (12 minutes) .....
3,000
400
1
400
12.5 ........................
5,000
250
1
250
45 ...........................
11,250
240
1,163
279,120
1 .............................
279,120
240
1,163
279,120
1 .............................
279,120
240
1
240
2.5 ..........................
600
145
1,408
204,160
1 .............................
204,160
120
1
120
15 ...........................
1,800
260
1
260
2 .............................
520
50
1
50
12.6 ........................
630
15,000
Frm 00050
4
1
15,000
0.4 (24 minutes) .....
6,000
Fmt 4703
Sfmt 4703
E:\FR\FM\20APN1.SGM
20APN1
18654
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total
annual
records
Average burden per
recordkeeping
Total
hours
111.535, Records for returned dietary supplements ...
111.570, Records regarding product complaints ........
110
240
4
600
440
144,000
13.5 ........................
0.5 (30 minutes) .....
5,940
72,000
Total ......................................................................
........................
........................
........................
................................
929,140
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping
estimates in table 1 are based on those
in the June 25, 2007, final rule, which
were based on our institutional
experience with other CGMP
requirements and on data provided by
Research Triangle Institute in the
‘‘Survey of Manufacturing Practices in
the Dietary Supplement Industry’’ cited
in that rule.
The estimates in table 1 of the number
of firms affected by each provision of
part 111 are based on the percentage of
manufacturers, packagers, labelers,
holders, distributors, and warehousers
that reported in the survey that they
have not established written SOPs or do
not maintain records that were later
required by the June 25, 2007, final rule.
Because we do not have survey results
for general warehouses, we entered the
approximate number of facilities in that
category for those provisions covering
general facilities. For the dietary
supplement industry, the survey
estimated that 1,460 firms would be
covered by the final rule, including
manufacturers, packagers, labelers,
holders, distributors, and warehousers.
The time estimates include the burden
involved in documenting that certain
requirements are performed and in
recordkeeping. We used an estimated
annual batch production of 1,408
batches per year to estimate the burden
of requirements that are related to the
number of batches produced annually,
such as § 111.260, ‘‘What must the batch
production record include?’’ The
estimate of 1,408 batches per year is
near the midpoint of the number of
annual batches reported by survey
firms.
The length of time that CGMP records
must be maintained is set forth in
§ 111.605. Table 1 reflects the estimated
burdens for written procedures, record
maintenance, periodically reviewing
records to determine if they may be
discarded, and for any associated
documentation for that activity for
records that are required under part 111.
We have not included a separate
estimate of burden for those sections
that require maintaining records in
accordance with § 111.605, but have
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
included those burdens under specific
provisions for keeping records. For
example, § 111.255(a) requires that the
batch production records be prepared
every time a batch is manufactured, and
§ 111.255(d) requires that batch
production records be kept in
accordance with § 111.605. The
estimated burdens for both § 111.255(a)
and (d) are included under § 111.260,
what the batch record must include.
Dated: April 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–07965 Filed 4–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 08N146B, Rockville, MD
20857; (301) 443–6593, or visit our Web
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
March 1, 2017, through March 31, 2017.
This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
E:\FR\FM\20APN1.SGM
20APN1
Agencies
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18652-18654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07965]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1619]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements
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 (PRA).
DATES: Fax written comments on the collection of information by May 22,
2017.
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 0910-0606.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
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.
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111; OMB Control Number 0910-0606--Extension
On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section
402(g)(2) of the FD&C Act provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practices for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
current good manufacturing practice (CGMP) regulations for food and may
not impose standards for which there are no current, and generally
available, analytical methodology. Section 402(g)(1) of the FD&C Act
states that a dietary supplement is adulterated if ``it has been
prepared, packed, or held under conditions that do not meet current
good manufacturing practice regulations.'' Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may issue regulations necessary for
the efficient enforcement of the FD&C Act. In the Federal Register of
June 25, 2007 (72 FR 34752), (the June 25, 2007, final rule), FDA
published a final rule that established, in part 111 (21 CFR part 111),
the minimum CGMP necessary for activities related to manufacturing,
packaging, labeling, or holding dietary supplements to ensure the
quality of the dietary supplement.
Records are an indispensable component of CGMP. The records
required by FDA's regulations in part 111 provide the foundation for
the planning, control, and improvement processes that constitute a
quality control system. Implementation of these processes in a
manufacturing operation serves as the backbone to CGMP. The records
show what is to be manufactured; what was, in fact, manufactured; and
whether the controls that the manufacturer put in place to ensure the
identity, purity, strength, and composition and limits on contaminants
and to prevent adulteration were effective. Further, records will show
whether and what deviations from control processes occurred, facilitate
evaluation and corrective action concerning these deviations
(including, where necessary, whether associated batches of product
should be recalled from the marketplace), and enable a manufacturer to
assure that the corrective action was effective. In addition, by
establishing recordkeeping requirements, FDA can ensure that industry
follows CGMP during manufacturing, packaging, labeling, or holding
operations. The regulations in part 111 establish the minimum
manufacturing practices necessary to ensure that dietary supplements
are manufactured, packaged, labeled, or held in a manner that will
ensure the quality of the dietary supplements during manufacturing,
packaging, labeling or holding operations.
The recordkeeping requirements of the regulations include
establishing written procedures and maintaining records pertaining to:
(1) Personnel; (2) sanitation; (3) calibration of instruments and
controls; (4) calibration, inspection, or checks of automated,
mechanical, or electronic equipment; (5) maintaining, cleaning, and
sanitizing equipment and utensils and other contact surfaces; (6) water
used that may become a component of the dietary supplement; (7)
production and process controls; (8) quality control; (9) components,
packaging, labels and product received for packaging and labeling; (10)
master manufacturing and batch production; (11) laboratory operations;
(12) manufacturing operations; (13) packaging and labeling operations;
(14) holding and distributing operations; (15) returned dietary
supplements; and (16) product complaints.
Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
The recordkeeping requirements of the regulations in part 111 are
set forth in each subpart. In table 1, we list the annual burdens
associated with recordkeeping, as described in the June 25, 2007, final
rule. For some provisions listed in table 1, we did not estimate the
number of records per recordkeeper because recordkeeping occasions
consist of frequent brief entries of dates, temperatures, monitoring
results, or documentation that specific actions were taken. Information
might be recorded a few times a day, week, or month. When the records
burden involves frequent brief entries, we entered 1 as the default for
the number of records per recordkeeper. For example, many of the
records listed under Sec. 111.35 in table 1, such as Sec.
111.35(b)(2) (documentation, in individual equipment logs, of the date
of the use, maintenance, cleaning, and sanitizing of equipment),
involve many
[[Page 18653]]
short sporadic entries over the course of the year, varying across
equipment and plants in the industry. We did not attempt to estimate
the actual number of recordkeeping occasions for these provisions, but
instead entered an estimate of the average number of hours per year. We
entered the default value of 1 as the number of records per
recordkeeper for these and similar provisions. For Sec. 111.35, the
entry for number of records is 1 as a default representing a large
number of brief recordkeeping occasions.
In many rows of table 1, we list a burden under a single provision
that covers the written procedures or records described in several
provisions. For example, the burden of the batch production records
listed in table 1 under Sec. 111.260 includes the burden for records
listed under Sec. 111.255 because the batch production records must
include those records.
The number of records for batch production records (and other
records kept on a batch basis in table 1) equals the annual number of
batches. The estimated burden for records kept by batch includes both
records kept for every batch and records kept for some but not all
batches. We use the annual number of batches as the number of records
that will not necessarily be kept for every batch, such as test results
or material review and disposition records, because such records are
part of records, if they are necessary, that will be kept for every
batch.
In the Federal Register of September 29, 2016 (81 FR 66967), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two commenters.
(Comment 1) One commenter had concerns about whether the processes
being used to assess the contents of supplements are genuine and
accurate and how this is regulated; whether records regarding labeling
indicate what is actually contained in a supplement; and whether these
records will be available to the public.
These comments appear to address PRA issues of practical utility
and ways to enhance the quality, utility, and clarity of the
information to be collected.
(Response 1) In this collection of information, FDA is evaluating
the burden of retaining records and making them available to regulatory
officials, but not the burden for proactively submitting them to FDA.
FDA reviews the records maintained while conducting an investigation
(e.g., during a facility inspection and during the followup
communication until a particular investigation is closed out). The
investigation of a particular firm by FDA is exempt from the PRA and is
not included as part of the burden estimate. The required elements of
labeling are part of different regulations and do not apply to this
collection of information. The commenter also discussed the safety of a
particular product but CGMP regulations deal with establishing a
quality product, not necessarily a safe product. Finally, the commenter
discussed allowing the records maintained to be made public. These
records are required to be maintained by the firm and are not
proactively submitted to FDA, but they are required to be made
available to FDA during inspections. If FDA obtains these records
during the investigation of a firm, the public can submit a Freedom of
Information Act request but the document they would typically receive
would be redacted because the records are the property of the firm.
(Comment 2) The second commenter stated that the labeling on
dietary supplement products should be consistent and FDA regulated, the
term ``healthy'' should be required to have a standard meaning, and
``healthy'' should not be allowed to be used unless it meets FDA
requirements of the term.
(Response 2) The recordkeeping for CGMPs has nothing to do with the
required elements of food and dietary supplement labeling, which are
covered under FDA's labeling regulations. FDA recently published, on
May 27, 2016, a final rule for Nutrition (and Supplement) Facts Labels
(81 FR 33741), and is currently reviewing new requirements for labeling
your food ``healthy''. This information collection for CGMP addresses
recordkeeping for specifications for a label and labeling operations.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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111.14, Records of personnel practices, 15,000 4 60,000 1........................................ 60,000
including documentation of training.
111.23, Records of physical plant sanitation 15,000 1 15,000 0.2 (12 minutes)......................... 3,000
practices, including pest control and water
quality.
111.35, Records of equipment and utensils 400 1 400 12.5..................................... 5,000
calibration and sanitation practices.
111.95, Records of production and process 250 1 250 45....................................... 11,250
control systems.
111.140, Records that quality control 240 1,163 279,120 1........................................ 279,120
personnel must make and keep.
111.180, Records associated with components, 240 1,163 279,120 1........................................ 279,120
packaging, labels, and product received for
packaging and labeling as a dietary
supplement.
111.210, Requirements for what the master 240 1 240 2.5...................................... 600
manufacturing record must include.
111.260, Requirements for what the batch 145 1,408 204,160 1........................................ 204,160
record must include.
111.325, Records that quality control 120 1 120 15....................................... 1,800
personnel must make and keep for laboratory
operations.
111.375, Records of the written procedures 260 1 260 2........................................ 520
established for manufacturing operations.
111.430, Records of the written procedures 50 1 50 12.6..................................... 630
for packaging and labeling operations.
111.475, Records of product distribution and 15,000 1 15,000 0.4 (24 minutes)......................... 6,000
procedures for holding and distributing
operations.
[[Page 18654]]
111.535, Records for returned dietary 110 4 440 13.5..................................... 5,940
supplements.
111.570, Records regarding product complaints 240 600 144,000 0.5 (30 minutes)......................... 72,000
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Total.................................... .............. .............. .............. ......................................... 929,140
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping estimates in table 1 are based
on those in the June 25, 2007, final rule, which were based on our
institutional experience with other CGMP requirements and on data
provided by Research Triangle Institute in the ``Survey of
Manufacturing Practices in the Dietary Supplement Industry'' cited in
that rule.
The estimates in table 1 of the number of firms affected by each
provision of part 111 are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written SOPs or
do not maintain records that were later required by the June 25, 2007,
final rule. Because we do not have survey results for general
warehouses, we entered the approximate number of facilities in that
category for those provisions covering general facilities. For the
dietary supplement industry, the survey estimated that 1,460 firms
would be covered by the final rule, including manufacturers, packagers,
labelers, holders, distributors, and warehousers. The time estimates
include the burden involved in documenting that certain requirements
are performed and in recordkeeping. We used an estimated annual batch
production of 1,408 batches per year to estimate the burden of
requirements that are related to the number of batches produced
annually, such as Sec. 111.260, ``What must the batch production
record include?'' The estimate of 1,408 batches per year is near the
midpoint of the number of annual batches reported by survey firms.
The length of time that CGMP records must be maintained is set
forth in Sec. 111.605. Table 1 reflects the estimated burdens for
written procedures, record maintenance, periodically reviewing records
to determine if they may be discarded, and for any associated
documentation for that activity for records that are required under
part 111. We have not included a separate estimate of burden for those
sections that require maintaining records in accordance with Sec.
111.605, but have included those burdens under specific provisions for
keeping records. For example, Sec. 111.255(a) requires that the batch
production records be prepared every time a batch is manufactured, and
Sec. 111.255(d) requires that batch production records be kept in
accordance with Sec. 111.605. The estimated burdens for both Sec.
111.255(a) and (d) are included under Sec. 111.260, what the batch
record must include.
Dated: April 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07965 Filed 4-19-17; 8:45 am]
BILLING CODE 4164-01-P