Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records, 7381-7383 [2019-03824]
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7381
Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
Topic/issue
Comment
ACL response
Social Events .......................
Question about the purpose of ‘‘social events held’’ and
whether it would be better to change to ‘‘social/recreation events held’’ to allow cost sharing with Title III.
The comments on the newly added finance section for
Part A/B were varied and ran from asking that the
question be removed and others asking for more options to share data.
Title III does not ask for this information. A social event,
as it is being defined in Title VI, can be recorded as
‘‘Other’’ in SPR.
ACL is sensitive to the burden that may be caused by
asking for new kinds of information from our grantees, we find that requiring this information will allow
us to better advocate for our programs and their financial needs. Based on the comments ACL has
added an optional text box for grantees to explain
more about their financial situations, and has also
added additional options under the section asking for
types of funding used.
ACL has updated the language in this section to be
less wordy and using the term ‘‘caregiver’’ rather
than ‘‘persons’’ to make it clearer that the intended
recipients of services are caregivers and not those
they care for.
ACL has chosen to maintain consistency in this area
with Title III’s SPR and will ensure that training and
technical materials make it clear how we are defining
Information and Assistance and how to best collect it.
ACL is sensitive to the burden that may be caused by
asking for new kinds of information from our grantees, we find that requiring this information will allow
us to better advocate for our programs and their financial needs. ACL chose respite care from the five
required services based on the thinking that the cost
of this service would be easier to track.
Finance Section for Part A/B
Caregiver (language) ...........
Suggestions to change some of the language in the
caregiver section to make it clearer.
Caregiver (Information and
Assistance).
There were a couple of suggestions that Information
and Assistance should be separated from one another.
Finance Section for Part C ..
Suggestion to not add the finance section and asking
for the cost of respite care to be pulled out.
The proposed form(s) may be found
on the ACL website at https://
www.acl.gov/about-acl/public-input.
Estimated Program Burden
Title VI funding is broken into three
categories. Parts A and B are for
nutritional and supportive
programming, and ask for the same
information. Part A is for American
Indian and Alaska Native grantees, and
Part B is for Native Hawaiian grantees.
Part C is for caregiver programming. All
Part C grantees must have Part A/B
funding; but not all Part A/B grantees
will have Part C programs. Therefore,
Number of
respondents
Respondent/data collection activity
there are 270 unique respondents, but
only 237 will have to complete all
portions of the PPR. ACL believes that
the increase in burden hours is justified
by the improved quality of the data and
will ultimately improve the services
provided to Native Elders.
Responses
per
respondent
Hours per
response
Annual burden
hours
PPR Part A/B ...................................................................................................
PPR Part C ......................................................................................................
270
237
1
1
1.83
1.66
494.1
393.4
Total ..........................................................................................................
........................
........................
........................
887.5
Dated: February 22, 2019.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–03847 Filed 3–1–19; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2018–N–3490]
BILLING CODE 4154–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exempt Infant
Formula Production: Current Good
Manufacturing Practices, Quality
Control Procedures, Conduct of
Audits, and Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
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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.
Fax written comments on the
collection of information by April 3,
2019.
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 0910–0811. Also
include the FDA docket number found
ADDRESSES:
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7382
Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
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, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Exempt Infant Formula Production:
Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures,
Conduct of Audits, and Records
OMB Control Number 0910–0811—
Extension
Section 412(h)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 350a(h)(1)) exempts an infant
formula that is represented and labeled
for use by an infant with an inborn error
of metabolism, low birth weight, or who
otherwise has an unusual medical or
dietary problem from the requirements
of section 412(a)–(c) of the FD&C Act.
These formulas are customarily referred
to as ‘‘exempt infant formulas.’’ Under
part 106 (21 CFR part 106), we
established requirements for quality
factors for infant formulas and CGMPs,
including quality control procedures.
This collection of information will help
prevent the manufacture of adulterated
infant formula, ensure the safety of
infant formula, and ensure that the
nutrients in infant formula are present
in a form that is bioavailable.
In the Federal Register of April 15,
2016 (81 FR 22174), we published a
notice of availability for the guidance
document entitled ‘‘Guidance for
Industry: Exempt Infant Formula
Production: Current Good
Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records and Reports.’’ The
guidance describes our current thinking
on the manufacturing of exempt infant
formula in relation to the requirements
in part 106 for CGMPs, quality control
procedures, conduct of audits, and
records and reports that apply to
nonexempt infant formulas. Persons
with access to the internet may obtain
the guidance at https://www.fda.gov/
FoodGuidances.
Our estimate of the burden of the
recordkeeping recommendations
includes the one-time burden of
developing production and in-process
control systems and the annual burdens
of developing and maintaining aggregate
production and control records, records
pertaining to the distribution of infant
formula, and records pertaining to
regularly scheduled audits. Included in
the burden estimate is the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information.
The guidance recommended, to the
extent practicable, that respondents
include records required by part 106,
subparts A, B, C, D, and F for nonexempt infant formulas. Because the
records and reporting requirements
related to part 106, subparts E and G are
not generally applicable to exempt
infant formula manufacturers, FDA is
not recommending in the guidance that
exempt infant formula manufacturers
follow these requirements. As such, the
records and reporting requirements in
part 106, subparts E and G are not part
of this information collection.
Description of Respondents: The
respondent recordkeepers are
manufacturers of exempt infant formula.
In the Federal Register of October 1,
2018 (83 FR 49393), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
First-Year Annual Burden:
Production and In-Process Control System—
106.6(c)(5) and 106.100(e)(1), and (e)(3).
Controls to Prevent Adulteration due to Automatic (Mechanical or Electronic) Equipment—
106.35(c) and 106.100(f)(5).
Total First Year Only Hourly Recordkeeping
Burden.
Recurring Annual Burden:
Controls to Prevent Adulteration Caused by Facilities—Testing for Radiological Contaminants—106.20(f)(3).
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Radiological
Contaminants—106.20(f)(4)
and
106.100(f)(1).
Controls to Prevent Adulteration Caused by Facilities—Testing for Bacteriological Contaminants—106.20(f)(3).
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Bacteriological Contaminants—106.20(f)(4) and
106.100(f)(1).
Controls to Prevent Adulteration by Equipment
or Utensils—106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment
or Utensils—106.30(e)(3)(iii) and 106.100(f)(3).
Controls to Prevent Adulteration by Equipment
or Utensils—106.30(f)(2) and 106.100(f)(4).
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Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeper
Total hours
3
1
3
40 ...........................
120
3
1
3
6,400 ......................
19,200
........................
........................
........................
................................
19,320
4
1
4
1.5 ..........................
6
4
1
4
0.08 (5 minutes) .....
0.32
3
52
156
0.08 (5 minutes) .....
12.48
3
52
156
0.08 (5 minutes) .....
12.48
3
52
156
0.21 (13 minutes) ...
32.76
3
52
156
0.21 (13 minutes) ..
32.76
3
52
156
0.19 (11 minutes) ..
29.64
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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
7383
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 recordkeeper
Total hours
Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment—
106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment—
106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Caused by Ingredients,
Containers,
and
Closures—
106.40(g) and 106.100(f)(6).
Controls to Prevent Adulteration During Manufacturing—106.50 and 106.100(e).
Controls to Prevent Adulteration From Microorganisms—106.55(d), 106.100(e)(5)(ii), and
106.100(f)(7).
Controls to Prevent Adulteration During Packaging and Labeling of Infant Formula—
106.60(c).
General Quality Control Testing—106.91(b)(1)–
(3).
General
Quality
Control—106.91(b)(1),
106.91(d), and 106.100(e)(5)(i).
General
Quality
Control—106.91(b)(2),
106.91(d), and 106.100(e)(5)(i).
General
Quality
Control—106.91(b)(3),
106.91(d), and 106.100(e)(5)(i).
Audit Plans and Procedures—106.94; Ongoing
Review and Updating of Audits.
Audit Plans and Procedures—106.94; Regular
Audits.
3
52
156
520 .........................
81,120
3
2
6
640 .........................
3,840
3
52
156
0.17 (10 minutes) ...
26.52
3
52
156
0.23 (14 minutes) ...
35.88
3
52
156
0.25 (15 minutes) ...
39
1
12
12
0.25 (15 minutes) ..
3
2
1
2
2 .............................
4
2
52
104
0.15 (9 minutes) .....
15.6
2
52
104
0.15 (9 minutes) .....
15.6
2
52
104
0.15 (9 minutes) .....
15.6
3
1
3
8 .............................
24
3
52
156
4 .............................
624
Total Recurring Recordkeeping Burden .......
........................
........................
........................
................................
85,889.64
Total Recordkeeping Burden ........................
........................
........................
........................
................................
105,209.64
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we made a correction since
the last OMB approval. While the onetime estimated recordkeeping burden
remains as 19,320 hours, we increased
the annual estimated recurring
recordkeeping burden to 85,889.64
hours due to a calculation error (a
79,561.58 hour increase) for a total
recordkeeping burden of 105,209.64
hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
HHS.
[FR Doc. 2019–03824 Filed 3–1–19; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2018–N–3240]
List of Bulk Drug Substances for
Which There Is a Clinical Need Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA or Agency) is
evaluating substances that have been
nominated for inclusion on a list of bulk
drug substances (active pharmaceutical
ingredients) for which there is a clinical
need (the 503B Bulks List). Drug
products that outsourcing facilities
compound using bulk drug substances
on the 503B Bulks List can qualify for
certain exemptions from the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) provided certain conditions are
met. This notice identifies two bulk
drug substances that FDA has
SUMMARY:
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considered and is not including on the
list at this time: Nicardipine
hydrochloride and vasopressin.
Additional bulk drug substances
nominated by the public for inclusion
on this list are currently under
consideration and will be the subject of
future notices.
DATES: The announcement of the notice
is published in the Federal Register on
March 4, 2019.
ADDRESSES: Submit electronic
comments on bulk drug substances
nominated for the 503B Bulks List to
Docket No. FDA–2015–N–3469. Submit
written comments on bulk drug
substances nominated for the 503B
Bulks List to the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Hankla, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5216,
E:\FR\FM\04MRN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7381-7383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3490]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exempt Infant Formula
Production: Current Good Manufacturing Practices, Quality Control
Procedures, Conduct of Audits, and Records
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 April
3, 2019.
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 0910-0811.
Also include the FDA docket number found
[[Page 7382]]
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, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
PRAStaff@fda.hhs.gov.
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.
Exempt Infant Formula Production: Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records
OMB Control Number 0910-0811--Extension
Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is
represented and labeled for use by an infant with an inborn error of
metabolism, low birth weight, or who otherwise has an unusual medical
or dietary problem from the requirements of section 412(a)-(c) of the
FD&C Act. These formulas are customarily referred to as ``exempt infant
formulas.'' Under part 106 (21 CFR part 106), we established
requirements for quality factors for infant formulas and CGMPs,
including quality control procedures. This collection of information
will help prevent the manufacture of adulterated infant formula, ensure
the safety of infant formula, and ensure that the nutrients in infant
formula are present in a form that is bioavailable.
In the Federal Register of April 15, 2016 (81 FR 22174), we
published a notice of availability for the guidance document entitled
``Guidance for Industry: Exempt Infant Formula Production: Current Good
Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of
Audits, and Records and Reports.'' The guidance describes our current
thinking on the manufacturing of exempt infant formula in relation to
the requirements in part 106 for CGMPs, quality control procedures,
conduct of audits, and records and reports that apply to nonexempt
infant formulas. Persons with access to the internet may obtain the
guidance at https://www.fda.gov/FoodGuidances.
Our estimate of the burden of the recordkeeping recommendations
includes the one-time burden of developing production and in-process
control systems and the annual burdens of developing and maintaining
aggregate production and control records, records pertaining to the
distribution of infant formula, and records pertaining to regularly
scheduled audits. Included in the burden estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
The guidance recommended, to the extent practicable, that
respondents include records required by part 106, subparts A, B, C, D,
and F for non-exempt infant formulas. Because the records and reporting
requirements related to part 106, subparts E and G are not generally
applicable to exempt infant formula manufacturers, FDA is not
recommending in the guidance that exempt infant formula manufacturers
follow these requirements. As such, the records and reporting
requirements in part 106, subparts E and G are not part of this
information collection.
Description of Respondents: The respondent recordkeepers are
manufacturers of exempt infant formula.
In the Federal Register of October 1, 2018 (83 FR 49393), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
First-Year Annual Burden:
Production and In-Process Control System-- 3 1 3 40....................................... 120
106.6(c)(5) and 106.100(e)(1), and
(e)(3).
Controls to Prevent Adulteration due to 3 1 3 6,400.................................... 19,200
Automatic (Mechanical or Electronic)
Equipment--106.35(c) and 106.100(f)(5).
----------------------------------------------------------------------------------------------------------
Total First Year Only Hourly .............. .............. .............. ......................................... 19,320
Recordkeeping Burden.
Recurring Annual Burden:
Controls to Prevent Adulteration Caused 4 1 4 1.5...................................... 6
by Facilities--Testing for Radiological
Contaminants--106.20(f)(3).
Controls to Prevent Adulteration Caused 4 1 4 0.08 (5 minutes)......................... 0.32
by Facilities--Recordkeeping of Testing
for Radiological Contaminants--
106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration Caused 3 52 156 0.08 (5 minutes)......................... 12.48
by Facilities--Testing for
Bacteriological Contaminants--
106.20(f)(3).
Controls to Prevent Adulteration Caused 3 52 156 0.08 (5 minutes)......................... 12.48
by Facilities--Recordkeeping of Testing
for Bacteriological Contaminants--
106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration by 3 52 156 0.21 (13 minutes)........................ 32.76
Equipment or Utensils--106.30(d)(1) and
106.100(f)(2).
Controls to Prevent Adulteration by 3 52 156 0.21 (13 minutes)........................ 32.76
Equipment or Utensils--106.30(e)(3)(iii)
and 106.100(f)(3).
Controls to Prevent Adulteration by 3 52 156 0.19 (11 minutes)........................ 29.64
Equipment or Utensils--106.30(f)(2) and
106.100(f)(4).
[[Page 7383]]
Controls to Prevent Adulteration Due to 3 52 156 520...................................... 81,120
Automatic (Mechanical or Electronic)
Equipment--106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Due to 3 2 6 640...................................... 3,840
Automatic (Mechanical or Electronic)
Equipment--106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Caused 3 52 156 0.17 (10 minutes)........................ 26.52
by Ingredients, Containers, and
Closures--106.40(g) and 106.100(f)(6).
Controls to Prevent Adulteration During 3 52 156 0.23 (14 minutes)........................ 35.88
Manufacturing--106.50 and 106.100(e).
Controls to Prevent Adulteration From 3 52 156 0.25 (15 minutes)........................ 39
Microorganisms--106.55(d),
106.100(e)(5)(ii), and 106.100(f)(7).
Controls to Prevent Adulteration During 1 12 12 0.25 (15 minutes)........................ 3
Packaging and Labeling of Infant
Formula--106.60(c).
General Quality Control Testing-- 2 1 2 2........................................ 4
106.91(b)(1)-(3).
General Quality Control--106.91(b)(1), 2 52 104 0.15 (9 minutes)......................... 15.6
106.91(d), and 106.100(e)(5)(i).
General Quality Control--106.91(b)(2), 2 52 104 0.15 (9 minutes)......................... 15.6
106.91(d), and 106.100(e)(5)(i).
General Quality Control--106.91(b)(3), 2 52 104 0.15 (9 minutes)......................... 15.6
106.91(d), and 106.100(e)(5)(i).
Audit Plans and Procedures--106.94; 3 1 3 8........................................ 24
Ongoing Review and Updating of Audits.
Audit Plans and Procedures--106.94; 3 52 156 4........................................ 624
Regular Audits.
----------------------------------------------------------------------------------------------------------
Total Recurring Recordkeeping Burden. .............. .............. .............. ......................................... 85,889.64
----------------------------------------------------------------------------------------------------------
Total Recordkeeping Burden........... .............. .............. .............. ......................................... 105,209.64
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection, we made a
correction since the last OMB approval. While the one-time estimated
recordkeeping burden remains as 19,320 hours, we increased the annual
estimated recurring recordkeeping burden to 85,889.64 hours due to a
calculation error (a 79,561.58 hour increase) for a total recordkeeping
burden of 105,209.64 hours.
Dated: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03824 Filed 3-1-19; 8:45 am]
BILLING CODE 4164-01-P
