[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46537-46543]
[FR Doc No: 2019-19030]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0242]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practices for Positron Emission Tomography Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
4, 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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0667.
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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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 (CGMP) for Positron Emission
Tomography (PET) Drugs

OMB Control Number 0910-0667--Extension

    PET is a medical imaging modality involving the use of a unique
type of radiopharmaceutical drug product. Our CGMP regulations at part
212 (21 CFR part 212) are intended to ensure that PET drug products
meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) regarding safety, identity, strength, quality, and purity. The
CGMP requirements for PET drugs are issued under the provisions of the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115). These CGMP requirements are designed according to the unique
characteristics of PET drugs, including their short half-lives, and the
fact that most PET drugs are produced at locations close to the
patients to whom the drugs are administered.
    The CGMP regulations require the establishment of written
procedures as well as recordkeeping related to ongoing manufacturing of
individual PET drugs, testing, and product release activities,
including any third-party disclosure requirements for producing PET
drugs. To estimate time spent to comply with the requirements, we
relied on informal communications with PET producers, FDA staff visits
to PET facilities, our familiarity with PET and general pharmaceutical
manufacturing practices with application and supplement submissions,
and various reports FDA received from 2016 through 2018.

I. Investigational and Research PET Drugs

    Section 212.5(b) provides that for investigational PET drugs
produced under an investigational new drug application (IND) and
research PET drugs produced with approval of a Radioactive Drug
Research Committee (RDRC), the requirement (FD&C Act) to follow CGMP is
met by complying with the regulations under part 212 or complying with
United States Pharmacopeia (USP) 32 Chapter 823. We believe that PET
production facilities producing drugs under INDs and RDRCs are already
substantially complying with the recordkeeping requirements of USP 32
Chapter 823 (see section 121(b) of FDAMA). Some IND and RDRC PET
facilities also produce approved NDA (new drug application) and
abbreviated new drug application (ANDA) PET drugs. While we do not have
sufficient information to estimate burdens for all IND and RDRC PET
facilities, our estimates have included those facilities that also
produce NDA and ANDA PET drugs. Those facilities are included under
academic and small firms.

II. Recordkeeping Burden

A. One-Time Burden for Corporate Firms

    We estimate corporate firms will have to employ one-time and
ongoing annual recordkeeping. There are three major PET manufacturing
corporations and most of the quality, manufacturing, and testing
procedures are developed at the corporate level and then issued to the
individual sites located in various States across the country. There
are an estimated 115 such sites under three major corporations. Thus,
the burden has been calculated for 3 recordkeepers instead of 115
individual sites.
    It would take approximately 8 hours for each corporate firm to
create one master batch record per drug, and an average of three PET
drugs have been taken into consideration. We also estimate that
approximately 3 firms will create and maintain approximately 27 records
associated with production and quality testing for an average of 3
drugs, with a total recordkeeping burden of approximately 216 hours.
    Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) (21 CFR
212.20(c), 212.30(b), 212.50(d), and 212.60(f)) contain standard
operating procedures (SOPs) dealing with equipment operation,
maintenance, and cleaning, including maintenance of physical
facilities.
    It would take approximately 5 hours for each corporate firm to
establish and maintain procedures for equipment and facility
maintenance. We estimate that the 3 corporate firms will establish and
maintain 39 procedures, with a total recordkeeping burden of
approximately 195 hours.
    Sections 212.20(c) and 212.40(a) and (b) contain requirements on
SOPs regarding receiving, testing, and accepting components. We
estimate that the burden for corporate firms to create procedures for
acceptance of raw materials and components would be approximately 8
hours and that there will be approximately three corporate firms
performing these activities, with a total recordkeeping burden of
approximately 48 hours. The burden for corporate firms to create
component specification data sheets would be approximately 2 hours with
approximately 3 corporate firms performing these activities, with a
total recordkeeping burden of approximately 150 hours for approximately
25 component specification sheets for each firm.
    Sections 212.20(c) and 212.71(a) and (b) require that PET drug
firms establish procedures for investigating ``deviations'' and ``out
of specifications failures'' of products during manufacturing and
testing that do not conform to specifications and to conduct these
investigations and record them as needed. We estimate that it will take
approximately 8 hours for three corporate firms to establish one
procedure, with a total recordkeeping burden of approximately 24 hours.
    Sections 212.20(c) and 212.90(a) require that written procedures
regarding distribution of PET drug products be established and
maintained. We estimate that it will take approximately 8 hours for
each corporate firm to establish written procedures regarding
distribution of PET drugs with a total of approximately three records,
with a total recordkeeping burden of approximately 24 hours.
    Sections 212.20(c) and 212.100(a), (b), and (c) require that PET
drug firms establish and maintain written procedures for handling
complaints and procedures for field alert reports (FARs). We estimate
that each corporate firm will create three written procedures to
establish complaints and FARs process and it will take approximately 24
hours for each corporate firm. A total of 72 hours will be required to
create 27 procedures by 3 corporate firms.

B. One-Time Burden for Academia, Small Firms, and Precursors

    There is a total of 52 sites combined for academic and small
commercial firms, including some IND and RDRC sites. There are nine
starting material/precursors/sterile raw material manufacturing
entities who are required to follow selected regulations from part 212,
according to the PET drug definition under section 121(a) of FDAMA and
codified in section 201(ii)(1)(A) of the FD&C Act (21 U.S.C.
321(ii)(1)(A)). We will refer to them as high-risk component
manufacturing firms in the tables and other sections of this document.

    It would take approximately 8 hours for each firm to perform the
same activities as corporate firms regarding creating master batch
records and manufacturing and quality procedures. We estimate that
there will be a total of approximately 488 records, with a total
recordkeeping burden of approximately 3,904 hours.
    It would take approximately 8 hours for each firm to create
equipment and facility related procedures as corporate firms. We also
estimate that there will be a total of approximately 793 records, with
a total recordkeeping burden of approximately 6,344 hours.
    We also estimate that the burden for each firm to create and
maintain specification sheets would be approximately 2 hours and that
there will be a total of approximately 61 firms performing these
activities, with a total recordkeeping burden of approximately 3,050
hours. Furthermore, the burden for these firms to create and maintain
procedures for acceptance of raw materials and components would be
approximately 8 hours and that there will be a total of approximately
61 firms performing these activities, with a total recordkeeping burden
of approximately 976 hours.
    It would take approximately 8 hours for each firm to perform the
same activities as corporate firms. We estimate that there will be a
total of approximately 61 records, with a total recordkeeping burden of
approximately 488 hours.
    We estimate that 61 academia, small firms, and high-risk component
manufacturers will create about one procedure related to deviations and
out of specifications and that each firm will expend approximately 8
hours, for a total of 488 hours. Similarly, 488 hours will be spent for
procedures on distribution of PET drugs. There will be 3 procedures
created by each firm related to customer complaints, recalls, and FARs,
with a total of 156 records from 52 sites and a total of 1,248 hours.

C. Annual Burden for Corporate Firms

    In this section, we considered 115 individual corporate sites under
the 3 major corporations in our estimates. These activities will be
related to individual PET drugs manufactured at each of the sites
located across the country. We estimate that it would take 30 minutes
each to fill 144 batches (approximately 4 batches/month), for a total
of 8,280 hours. In the second row of table 3, we have also estimated
that on an annual basis, some new batch records or quality records may
have to be created for newly introduced or existing drugs. It would
take each firm approximately 24 hours for three new quality procedure/
master batch records, with a total recordkeeping burden of
approximately 216 hours for nine records from three corporate
organizations.
    We estimate that 115 individual corporate sites belonging to 3
major corporate entities will create 164 records for equipment
maintenance, cleaning, calibration, and facilities maintenance records,
with a total recordkeeping burden of 9,430 hours.
    Sections 212.20(c) and 212.40(a) and (b) also set out requirements
for raw material and component shipments received at the manufacturing
facility on an ongoing basis. We estimate that the burden for each firm
to create incoming raw material acceptance records for 2 shipments per
month and 30 minutes per shipment will be 1,380 hours for 2,760 records
from 115 sites.
    Sections 212.60(g), 212.61(b), and 212.70(d)(2) and (3) set out
requirements for documenting laboratory testing results from each PET
drug manufactured referred to in laboratory testing, including final
release testing. Each firm must keep records of different tests for
each of their products. We estimate that approximately 115 corporate
sites will document 144 records of cumulative quality control (QC) test
results (one record with 5 to 6 tests included), with a total
recordkeeping burden of approximately 8,280 hours.
    We estimate that each firm will take approximately 1 hour to record
out-of-specification (OOS) events and perform investigations for each
incident. We also estimate an average of 2 ``Out of Specification''
investigations per firm, with a total of 230 records for ``OOS''
investigations from 115 sites, which results in a burden of 460 hours.
This estimate includes any reprocessing or special release events,
which are very rare.
    Section 212.100(b) and (c) requires that PET drug firms document
how each complaint is handled. We estimate that this will take
approximately 2 hours for each site to document and investigate one
complaint. We estimated 2 complaints per year per site, with a total
expended hour of 460 hours for 115 individual sites. We believe the
estimate is appropriate since not all sites receive complaints.
    We also estimate annual recordkeeping for PET drug firms to perform
quality assurance (QA) and release of manufactured PET drugs from the
115 corporate sites to be 4,140 hours, for a total of 144 released
batches estimating 15 minutes per batch.
    Section 212.90(b) requires that corporate firms maintain
distribution records. We estimate that it will take each firm
approximately 15 minutes to create a distribution record for each batch
of PET drug products, with a total burden of approximately 4,140 hours
for 144 released batches from 115 sites.

D. Annual Burden for Academia and Small Firms

    It is estimated that each firm will expend the same amount of time
to perform the same activities as corporate firms. Approximately 52
academia and small firms will fill 1,248 batch and production records,
totaling 624 hours. For any new master batch record or quality
procedures we have estimated 156 total records (3 per site), with a
total of 1,248 hours.
    For calibration and cleaning records like filling information in
log books for each piece of equipment and documenting calibration
records in each PET production firm, we estimate approximately 30
minutes on average for each piece of equipment for all firms. The
calibration efforts are once per year per equipment, with estimated 10
pieces of equipment per site. We estimate that 52 academic and small
firms will record a total of 884 hours for 34 records per site and a
total of 1,768 records.
    For Sec. Sec.  212.20(c) and 212.40(a) and (b), approximately 1,768
raw material and component acceptance records will be filled on an
ongoing annual basis. We estimate that the burden for each firm to
create incoming raw material acceptance records for 12 shipments per
year and 30 minutes per shipment will be 312 hours for 624 records from
52 sites.
    We also estimate that approximately 52 academia and small firms
will document 1,248 laboratory QC tests for 24 batches of drugs, with a
total recordkeeping burden of approximately 624 hours.
    We estimate that each firm will take approximately 1 hour each to
record OOS and customer complaint events and perform investigations. We
also estimate that an average of two ``Out of Specification'' and
customer complaints and investigations per firm, with a total of 208
hours for each category. This estimate has included any reprocessing or
special batch release events, which have been rarely observed.
    We also estimate annual recordkeeping for PET drug firms to perform
QA and release of manufactured PET drugs from 52 sites to be 312 hours,
for a total of 24 batches per site released if estimating 15 minutes
per batch.

    Section 212.90(b) requires that corporate firms maintain
distribution records. We estimate that it will take approximately 15
minutes to create a distribution record for each batch of PET drug
products, with a total burden of approximately 312 hours for 24 batches
per site.

E. Annual Burden for High-Risk Component Manufacturers

    According to section 121(a) of FDAMA, the PET drug definition
includes any non-radioactive or radioactive reagents, kits, nuclidic
generators, target materials, synthesizers, and so forth. FDA performs
risk assessments of each manufacturer and inspects such manufacturers.
Sterile manufacturers and complex labels fall under this category,
including sterile raw material or reagent manufactures. We have
estimated nine such facilities based on inspections so far and have
included them in this section. These manufacturers must comply with
selected sections of part 212 since they are not final PET drug
manufacturers. We will refer to them as high-risk component
manufacturers in general in this document.
    We estimate that it would take 9 high-risk component manufacturers
about 30 minutes to fill each manufacturing batch records (12 per year)
and that there will be a total of approximately 108 records, with a
total recordkeeping burden of approximately 54 hours.
    We also estimate that it will take nine component manufacturers 30
minutes to fill and create equipment and facilities related records,
with a total recordkeeping burden of 72 hours.
    We estimate that 9 high-risk component manufacturers will document
54 components, containers, and closures for incoming acceptance tests,
with a total recordkeeping burden of approximately 27 hours.
    We estimate that 9 high-risk component manufacturers will document
12 QC records related to 12 batches, with a total recordkeeping burden
of approximately 54 hours.
    We also estimate annual recordkeeping for PET drug firms to perform
QA and release manufactured PET drugs from 9 sites to be 27 hours, for
a total of 108 batches released, estimating 15 minutes per batch.
    We further estimate that it would take each precursor 15 minutes to
create and maintain distribution records and that there will be
approximately 108 records, with a total recordkeeping burden of
approximately 27 hours.

III. Process Verification

    Section 212.50(f)(2) requires that any process verification
activities and results be recorded. Process verification is usually
performed as a one-time activity before a product is approved or if any
major manufacturing process or equipment changes are made. This effort
to conduct process verification has been estimated under annual new
creation of master batch records and manufacturing and quality
procedures in section II of this document.

IV. Conditional Final Releases

    Section 212.70(f) requires PET drug producers to document any
conditional final releases of a product. We believe that conditional
final releases will be uncommon, and we have them estimated under
annual ``OOS'' investigations and final QA release efforts for each
manufactured batch.

V. Reprocessing Procedures

    Sections 212.20(c) and 212.71(d) require PET drug producers to
establish and document procedures for reprocessing PET drugs. We rarely
see any reprocessing option being submitted for application of such
drugs and, if reprocessing occurs, we have estimated such rare events
under annual QA release efforts.

VI. Third-Party Disclosure Burden

    Section 212.70(e) requires that PET drug producers notify all
receiving facilities if a batch fails sterility tests. FDA receives
FARs reports based on confirmed sterility failures of released PET
drugs. Based on our experience of such reporting, we estimated a total
of 12 failures from all 167 sites (corporate, small firms, and
academia). Therefore, we have estimated that 12 PET drug producers will
file 2 reports to FDA and send a notification to the affected clinical/
receiving site per year. PET drug producers would transmit the notice
by email or Fax and submit the FARs notice to FDA electronically, with
2.5 hours per incident in total.
    In the Federal Register of November 30, 2018 (83 FR 61653), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received and are
summarized here.
    One comment questioned the necessity of this proposed collection.
One comment suggested that FDA allow both paper recordkeeping and
simplified electronic report submission. Two comments questioned some
of FDA's burden collection estimates. Two comments questioned whether
Annual Product Review (APR) is being required by the regulations. Two
comments pertained to an inadvertent oversight in section VI. Third-
Party Disclosure.
    FDA believes that this proposed collection is necessary in keeping
with the Agency's mission of ensuring the safety and efficacy of human
drugs. Regarding the estimates included, FDA has taken a generalized
approach for these estimates, assuming that corporate firms will take
on certain burdens for all facilities under their purview, rather than
calculating all burdens per facility, and understanding that due to
variation among facilities the number of batches and products being
produced will vary. We have also only included estimates for tasks that
are included within part 212 and note that some of the comments
referenced tasks, such as APR, that are outside that scope. Electronic
recordkeeping is also outside the scope of this regulation. Regarding
the typographical error in section VI. Third Party Disclosure, on page
9350, we estimate that it will take PET drug producers 2 hours to
submit to FDA notices of sterility test failures. We intended to
estimate 2.5 hours as accurately shown in Table 6, page 9352. In
section VI of this document, we have included this change. We
appreciate these comments and will continue to consider the burden
estimate. If commenters believe certain estimates are insufficient, we
request comments on specific estimates for these requirements and why
alternative estimates would be more accurate.
    The estimated burden of the information collection, therefore, is
as follows:

                    Table 1--Estimated One-Time Recordkeeping Burden for Corporate Firms \1\
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                                                     Number of                        Average
 Activity/type of respondent/21      Number of      records per      One-time       burden per      Total hours
           CFR section             recordkeepers   recordkeeper       records      recordkeeper         \2\
----------------------------------------------------------------------------------------------------------------
Batch Production and Control                   3               9              27               8             216
 Records (Sec.  Sec.   212.20(c)
 and (e) and 212.50(a) and (b)).

Equipment and Facilities Records               3              13              39               5             195
 (SOP) (Sec.  Sec.   212.20(c),
 212.30(b) 212.50(d), and
 212.60(f)).....................
Records of Components,                         3               2               6               8              48
 Containers, and Closures (SOP)
 (Sec.  Sec.   212.20(c) and
 212.40(a) and (b)).............
Records of Components,                         3              25              75               2             150
 Containers, and Closures
 (specifications data sheets)
 (Sec.  Sec.   212.20(c) and
 212.40(a) and (b)).............
Out-of-Specification                           3               1               3               8              24
 Investigations (SOP) (Sec.
 Sec.   212.20(c) and 212.71(a))
Distribution Records (SOP) (Sec.               3               1               3               8              24
  Sec.   212.20(c) and
 212.90(a)).....................
Complaints, Recalls (Sec.  Sec.                3               3               9               8              72
  212.20(c) and 212.100(a)).....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number rounded to the nearest whole number.

       Table 2--Estimated One-Time Recordkeeping Burden for Academia, Small Firms, and High-Risk Component
                                                Manufacturers \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Activity/type of respondent/21      Number of      records per      One-time       burden per      Total hours
           CFR section             recordkeepers   recordkeeper       records      recordkeeper         \2\
----------------------------------------------------------------------------------------------------------------
Batch Production and Control                  61               8             488               8           3,904
 Records (Sec.  Sec.   212.20(c)
 and (e) and 212.50(a) and (b)).
Equipment and Facilities Records              61              13             793               8           6,344
 (SOP) (Sec.  Sec.   212.20(c),
 212.30(b) 212.50(d), and
 212.60(f)).....................
Records of Components,                        61              25           1,525               2           3,050
 Containers, and Closures
 (specification only) (Sec.
 Sec.   212.20(c) and 212.40(a)
 and (b)).......................
Records of Components,                        61               2             122               8             976
 Containers, and Closures (SOP)
 (Sec.  Sec.   212.20(c) and
 212.40(a) and (b)).............
Out-of-Specification                          61               1              61               8             488
 Investigations (SOP) (Sec.
 Sec.   212.20(c) and 212.71(a))
Distribution Records (SOP) (Sec.              61               1              61               8             488
  Sec.   212.20(c) and
 212.90(a)).....................
Complaints, Recalls (Sec.  Sec.               52               3             156               8           1,248
  212.20(c) and 212.100(a)).....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          16,498
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number rounded to the nearest whole number.

                     Table 3--Estimated Annual Recordkeeping Burden for Corporate Firms \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper         \2\
----------------------------------------------------------------------------------------------------------------
Batch Production (Creating                   115             144          16,560          * 0.50           8,280
 Manufacturing Records (creating
 batch-related records per year)
 (Sec.  Sec.   212.20(c) and (e)
 and 212.50(a) and (b)).........
Creating Any New Batch Records/                3               9              27               8             216
 Quality Records for New or
 Existing Drugs (Sec.  Sec.
 212.20(c) and (e) and 212.50(a)
 and (b)).......................
Equipment and Facilities Records             115             164          18,860          * 0.50           9,430
 (calibration and cleaning
 records systems) (Sec.  Sec.
 212.30(b), 212.50(d), and
 212.60(f)).....................
Records of Components,                       115              24           2,760          * 0.50           1,380
 Containers, and Closures (Sec.
 Sec.   212.20(c) and 212.40(a)
 and (b)).......................
Laboratory Testing Records                   115             144          16,560          * 0.50           8,280
 (record laboratory test
 results) (Sec.  Sec.
 212.60(g), 212.61(b), and
 212.70(d)(2) and (3))..........
Out-of-Specification                         115               2             230               2             460
 Investigations (record events
 and investigations) (Sec.
 212.71(b)).....................
Complaints (Sec.  Sec.                       115               2             230               2             460
 212.100(b) and (c))............
QA and Release of Batches.......             115             144          16,560          + 0.25           4,140
Distribution Records (Sec.                   115             144          16,560          + 0.25           4,140
 212.90(b)).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          36,786
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number rounded to the nearest whole number.

* (30 minutes).
+ (15 minutes).

                 Table 4--Estimated Annual Recordkeeping Burden for Academia and Small Firms \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper         \2\
----------------------------------------------------------------------------------------------------------------
Batch Production (creating                    52              24           1,248          * 0.50             624
 manufacturing records) (filling
 batch related records per year)
 (Sec.  Sec.   212.20(c) and (e)
 and 212.50(a) and (b)).........
Creating Any New Batch Records/               52               3             156               8           1,248
 Procedures for New Drugs (Sec.
 Sec.   212.20(c) and (e) and
 212.50(a) and (b)).............
Equipment and Facilities Records              52              34           1,768          * 0.50             884
 (calibration and cleaning
 records) (Sec.  Sec.
 212.30(b), 212.50(d), and
 212.60(f)).....................
Records of Components,                        52              12             624          * 0.50             312
 Containers, and Closures
 (incoming acceptance tests)
 (Sec.  Sec.   212.20(c) and
 212.40(a) and (b)).............
Laboratory Testing Records (QC                52              24           1,248          * 0.50             624
 test results) (Sec.  Sec.
 212.60(g), 212.61(b) and
 212.70(d)(2) and (3))..........
Out-of-Specification                          52               2             104               2             208
 Investigations (record events
 and investigations) (Sec.
 212.71(b)).....................
Complaints (Record events and                 52               2             104               2             208
 investigations) (Sec.  Sec.
 212.100(b) and (c))............
QA and Release of Batches.......              52              24           1,248          + 0.25             312
Distribution Records (Sec.                    52              24           1,248          + 0.25             312
 212.90(b)).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,732
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number rounded to the nearest whole number.
* (30 minutes).
+ (15 minutes).

            Table 5--Estimated Annual Recordkeeping Burden for High Risk Component Manufacturers \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper         \2\
----------------------------------------------------------------------------------------------------------------
Batch Production (creating                     9              12             108          * 0.50              54
 manufacturing records and batch
 related records per year) (Sec.
  Sec.   212.20(c) and (e) and
 212.50(a) and (b)).............
Equipment and Facilities Records               9              16             144          * 0.50              72
 (calibration and cleaning
 records systems) (Sec.  Sec.
 212.30(b), 212.50(d), and
 212.60(f)).....................
Records of Components,                         9               6              54          * 0.50              27
 Containers, and Closures
 (incoming acceptance test)
 (Sec.  Sec.   212.20(c) and
 212.40(a) and (b)).............
Laboratory Testing Records                     9              12             108          * 0.50              54
 (record QC test results) (Sec.
 Sec.   212.60(g), 212.61(b) and
 212.70(d)(2) and (3))..........
Out-of-Specification                           9               1               9               1               9
 Investigations (Record events
 and investigations) (Sec.
 212.71(b)).....................
QA and Release of Batches.......               9              12             108          + 0.25              27
Distribution Records (Sec.                     9              12             108          + 0.25              27
 212.90(b)).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             270
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number rounded to the nearest whole number.
* (30 minutes).
+ (15 minutes).

                           Table 6--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                     Number of       Number of
                                     sterility      disclosures    Total annual       Average
     Activity/21 CFR section          failure           per         disclosures     burden per      Total hours
                                     incidents      respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
Sterility Test Failure Notices                12           \2\ 3              36             2.5              90
 (Sec.   212.70(e)).............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ There are two reports sent to FDA per incident and notification to receiving site.

    These burden estimates reflect adjustments since last OMB approval.
Previously we had based the estimated number of respondents on the
number of individual production sites, however we believe using the
number of registered organizations better reflects the burden
attributable to information collection. This results in an overall
decrease to the collection.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19030 Filed 9-3-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3668-3671]
[FR Doc No: 2015-01076]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 12d1-1; SEC File No. 270-526, OMB Control No. 3235-0584..

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    An investment company (``fund'') is generally limited in the amount
of securities the fund (``acquiring fund'') can acquire from another
fund (``acquired fund''). Section 12(d) of the Investment Company Act
of 1940 (the ``Investment Company Act'' or ``Act'') \1\ provides that a
registered fund (and companies it controls) cannot:
---------------------------------------------------------------------------

    \1\ See 15 U.S.C. 80a.
---------------------------------------------------------------------------

     Acquire more than three percent of another fund's
securities;
     invest more than five percent of its own assets in another
fund; or
     invest more than ten percent of its own assets in other
funds in the aggregate.\2\
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    \2\ See 15 U.S.C. 80a-12(d)(1)(A). If an acquiring fund is not
registered, these limitations apply only with respect to the
acquiring fund's acquisition of registered funds.
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    In addition, a registered open-end fund, its principal underwriter,
and any registered broker or dealer cannot sell that fund's shares to
another fund if, as a result:
     The acquiring fund (and any companies it controls) owns
more than three percent of the acquired fund's stock; or
     all acquiring funds (and companies they control) in the
aggregate own more than ten percent of the acquired fund's stock.\3\
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    \3\ See 15 U.S.C. 80a-12(d)(1)(B).
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    Rule 12d1-1 under the Act provides an exemption from these
limitations for ``cash sweep'' arrangements in which a fund invests all
or a portion of its available cash in a money market fund rather than
directly in short-term instruments.\4\ An acquiring fund relying on the
exemption may not pay a sales load, distribution fee, or service fee on
acquired fund shares, or if it does, the acquiring fund's investment
adviser must waive a sufficient amount of its advisory fee to offset
the cost of the loads or distribution fees.\5\ The acquired fund may be
a fund in the same fund complex or in a different fund complex. In
addition to providing an exemption from section 12(d)(1) of the Act,
the rule provides exemptions from section 17(a) of the Act and rule
17d-1 thereunder, which restrict a fund's ability to enter into
transactions and joint arrangements with affiliated persons.\6\ These
provisions would otherwise prohibit an acquiring fund from investing in
a money market fund in the same fund complex,\7\ and prohibit a fund
that acquires five percent or more of the securities of a money market
fund in another fund complex from making any additional investments in
the money market fund.\8\
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    \4\ See 17 CFR 270.12d1-1.
    \5\ See rule 12d1-1(b)(1).
    \6\ See 15 U.S.C. 80a-17(a), 15 U.S.C. 80a-17(d); 17 CFR
270.17d-1.
    \7\ An affiliated person of a fund includes any person directly
or indirectly controlling, controlled by, or under common control
with such other person. See 15 U.S.C. 80a-2(a)(3) (definition of
``affiliated person''). Most funds today are organized by an
investment adviser that advises or provides administrative services
to other funds in the same complex. Funds in a fund complex are
generally under common control of an investment adviser or other
person exercising a controlling influence over the management or
policies of the funds. See 15 U.S.C. 80a-2(a)(9) (definition of
``control''). Not all advisers control funds they advise. The
determination of whether a fund is under the control of its adviser,
officers, or directors depends on all the relevant facts and
circumstances. See Investment Company Mergers, Investment Company
Act Release No. 25259 (Nov. 8, 2001) [66 FR 57602 (Nov. 15, 2001)],
at n.11. To the extent that an acquiring fund in a fund complex is
under common control with a money market fund in the same complex,
the funds would rely on the rule's exemptions from section 17(a) and
rule 17d-1.
    \8\ See 15 U.S.C. 80a-2(a)(3)(A), (B).
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    The rule also permits a registered fund to rely on the exemption to
invest in an unregistered money market fund that limits its investments
to those in which a registered money market fund may invest under rule
2a-7 under the Act, and undertakes to comply with all the other
provisions of rule 2a-7.\9\ In addition, the acquiring fund must
reasonably believe that the unregistered money market fund (i) operates
in compliance with rule 2a-7, (ii) complies with sections 17(a), (d),
(e), 18, and 22(e) of the Act \10\ as if it were a registered open-end
fund, (iii) has adopted procedures designed to ensure that it complies
with these statutory provisions, (iv) maintains the records required by
rules 31a-1(b)(1), 31a-1(b)(2)(ii), 31a-1(b)(2)(iv), and 31a-1(b)(9);
\11\ and (v) preserves permanently, the first two years in an easily
accessible place, all books and records required to be made under these
rules.
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    \9\ See 17 CFR 270.2a-7.
    \10\ See 15 U.S.C. 80a-17(a), 15 U.S.C. 80a-17(d), 15 U.S.C.
80a-17(e), 15 U.S.C. 80a-18, 15 U.S.C. 80a-22(e).
    \11\ See 17 CFR 270.31a-1(b)(1), 17 CFR 270.31a-1(b)(2)(ii), 17
CFR 270.31a-1(b)(2)(iv), 17 CFR 270.31a-1(b)(9).
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    Rule 2a-7 contains certain collection of information requirements.
An unregistered money market fund that complies with rule 2a-7 would be
subject to these collection of information requirements. In addition,
the recordkeeping requirements under rule 31a-1 with which the
acquiring fund reasonably believes the unregistered money market fund
complies are collections of information for the unregistered money
market fund. The adoption of procedures by unregistered money market
funds to ensure that they comply with sections 17(a), (d), (e), 18, and
22(e) of the Act also constitute collections of information. By
allowing funds to invest in registered and unregistered money market
funds, rule 12d1-1 is intended to provide funds greater options for
cash management. In order for a registered fund to rely on the
exemption to invest

in an unregistered money market fund, the unregistered money market
fund must comply with certain collection of information requirements
for registered money market funds. These requirements are intended to
ensure that the unregistered money market fund has established
procedures for collecting the information necessary to make adequate
credit reviews of securities in its portfolio, as well as other
recordkeeping requirements that will assist the acquiring fund in
overseeing the unregistered money market fund (and Commission staff in
its examination of the unregistered money market fund's adviser).
    The number of unregistered money market funds that are affected by
rule 12d1-1 is an estimate based on the number of private liquidity
funds reported on Form PF as of May 7, 2014.\12\ The hour burden
estimates for the condition that an unregistered money market fund
comply with rule 2a-7 are based on the burden hours included in the
Commission's 2013 PRA submission regarding rule 2a-7.\13\ The estimated
average burden hours in this collection of information are made solely
for purposes of the Paperwork Reduction Act and are not derived from a
quantitative, comprehensive or even representative survey or study of
the burdens associated with Commission rules and forms.
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    \12\ See U.S. Securities and Exchange Commission Annual Staff
Report Relating to the Use of Data Collected from Private Fund
Systemic Risk Reports, Appendix A, Census PF Data as of May 7, 2014,
available at http://www.sec.gov/reportspubs/special-studies/im-private-fund-annual-report-081514.pdf. In the past, the staff has
estimated the number of affected unregistered money market funds
based on the latest number of exemptive applications received by the
Commission that sought relief for registered funds to purchase
shares in an unregistered money market fund in excess of the section
12(d)(1) limits. The staff's prior estimate of 30 affected
unregistered money market funds was based on 40 exemptive
applications received by the Commission in 2005 (the last full year
in which the Commission received applications seeking an exemption
to invest in unregistered money market funds in excess of the
statutory limits) and adjusted by the percentage change in
registered money market funds from 2005 to November 2011 (870 funds
to 641 funds, according to the Investment Company Institute). The
staff noted that this estimate may be understated because applicants
generally did not identify the name or number of unregistered money
market funds in which registered funds intended to invest, and each
application also applies to unregistered money market funds to be
organized in the future.
    \13\ See Securities and Exchange Commission, Request for OMB
Approval of Extension for Approved Collection for Rule 2a-7 under
the Investment Company Act of 1940 (OMB Control No. 3235-0268)
(approved Aug. 28, 2013). In connection with amendments to rule 2a-7
adopted in July 2014, the Commission also submitted a Revision of a
Currently Approved Collection for Rule 2a-7, which is not yet
approved. See Money Market Fund Reform, Investment Company Act
Release No. 31166 (July 23, 2014) [79 FR 47736 (Aug. 14, 2014)],
available at http://www.sec.gov/rules/final/2014/33-9616.pdf;
Securities and Exchange Commission, Revision of a Currently Approved
Collection (OMB Control No. 3235-0268) (pending, submitted September
4, 2014).
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    In the most recent rule 2a-7 submission, Commission staff made the
following estimates with respect to aggregate annual hour and cost
burdens for collections of information for each existing registered
money market fund:
    Record of credit risk analyses, and determinations regarding
adjustable rate securities, asset backed securities, securities subject
to a demand feature or guarantee, and counterparties to repurchase
agreements:

85 responses
680 hours of professional time
Cost: $178,160 \14\

    \14\ This estimate is based on the following calculation: (680
burden hours x $262 per hour for professional time) = $178,160 per
fund.
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    Public Web site posting of monthly portfolio information:
12 responses
7 hours of professional time
Cost: $17,304 \15\
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    \15\ This estimate is based on the following calculation: (12 x
7 burden hours x $206 per hour for a webmaster) = $17,304 per fund.
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    Review of procedures and guidelines of any investment adviser to
whom the fund's board has delegated responsibility under rule 2a-7 and
amendment of such procedures:

1 response
5 hours of professional and director time
Cost: $5,960 \16\

    \16\ This estimate is based on the following calculation: (1
hour x $4,500 per hour for board time) + (4 hours x $365 per hour
for professional time) = $5,960 per fund.
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    Based on new census data available on Form PF, the staff now
believes that the number of private liquidity funds reported on Form PF
(69) is a more current and accurate estimate the number of unregistered
money market funds affected by rule 12d1-1.\17\ Each of these
unregistered money market funds engages in the collections of
information described above. Accordingly, the staff estimates that
unregistered money market funds complying with the collections of
information described above engage in a total of 6,762 annual responses
under rule 12d1-1,\18\ the aggregate annual burden hours associated
with these responses is 47,748,\19\ and the aggregate annual cost to
funds is $13,898,256.\20\
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    \17\ See supra note 12. The staff notes, however, that this
estimate may be overstated to the extent that a private liquidity
fund reported on Form PF does not follow all of rule 2a-7's
requirements (that include collections of information) or because no
registered investment companies invest in such a fund. The staff
also notes, however, that this estimate may be understated to the
extent that there are additional unregistered money market funds
that are not required to be reported on Form PF (because Form PF is
filed only by certain investments advisers to private funds that
have $150 million in private fund assets under management).
    \18\ The estimate is based on the following calculations: (69
funds x 85 responses for documentation of credit analyses and other
determinations) = 5,865 responses. (69 funds x 12 responses for
public Web site posting) = 828 responses. (69 funds x 1 response for
policies and procedures related to delegation to an investment
adviser) = 69 responses. 5,865 responses + 828 responses + 69
responses = 6,762 responses.
    \19\ This estimate is based on the following calculations: (69
funds x 680 hours for documentation of credit analyses and other
determinations) = 46,920 hours. (69 funds x 7 hours for public Web
site posting) = 483 hours. (69 funds x 5 hours for policies and
procedures related to delegation to an investment adviser) = 345
hours. 46,920 hours + 483 hours + 345 hours = 47,748 hours.
    \20\ This estimate is based on the following calculations: (69
funds x $178,160) = $12,293,040. (69 funds x $17,304) = $1,193,976.
(69 funds x $5,960) = $411,240. $12,293,040 + $1,193,976 + $411,240
= $13,898,256.
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    In the rule 2a-7 submissions, Commission staff further estimated
the aggregate annual hour and cost burdens for collections of
information for fund complexes with registered money market funds as
follows:
    Review, revise, and approve procedures concerning stress testing:

1 response
12 burden hours of professional and director time
Cost: $8,021 \21\

    \21\ This estimate is based on the following calculation: (1
hour x $4,500 per hour for board time) + (5 hours x $322 per hour
for a portfolio manager) + (3 hours x $259 per hour for a risk
management specialist) + (3 hours x $378 per hour for an attorney) =
$8,021 per response.
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    Report to fund boards on the results of stress testing:

5 responses
10 burden hours of professional and support staff time
Cost: $15,490 \22\

    \22\ This estimate is based on the following calculation: (5
responses x 5 hours x $322 per hour for a portfolio manager) + (5
responses x 2 hours x $279 per hour for a compliance manager) + (5
responses x 2 hours x $378 per hour for an attorney) + (5 responses
x 1 hour x $174 per hour for support staff) = $15,490 per fund
complex.
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    Reporting of rule 17a-9 transactions: \23\
---------------------------------------------------------------------------

    \23\ See 17 CFR 270.17a-9.

1 response
1 burden hour of legal time
Cost: $378 \24\

    \24\ The estimate is based on the following calculations: (1
response x $378 per hour for an attorney) = $378 per response.
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    Based on the number of large liquidity fund advisers reported on
Form PF, the staff estimates that there are 25 fund complexes with
unregistered money market funds invested in by mutual

funds in excess of the statutory limits under rule 12d1-1.\25\ Each of
these fund complexes engages in the collections of information
described above. Accordingly, the staff estimates that these fund
complexes complying with the collections of information described above
engage in a total of 175 annual responses under rule 12d1-1,\26\ the
aggregate annual burden hours associated with these responses is
575,\27\ and the aggregate annual cost to funds is $597,225.\28\
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    \25\ See supra note 12.
    \26\ The estimate is based on the following calculations: (25
fund complexes x 1 response for revision of procedures concerning
stress testing) = 25 responses. (25 fund complexes x 5 responses to
provide stress testing reports) = 125 responses. (25 fund complexes
x 1 response for reporting of rule 17a-9 transactions) = 25
responses. 25 responses + 125 responses + 25 responses = 175
responses.
    \27\ This estimate is based on the following calculations: (25
fund complexes x 12 hours for revision of procedures concerning
stress testing) = 300 hours. (25 fund complexes x 10 hours to
provide stress testing reports) = 250 hours. (25 fund complexes x 1
hour for reporting of rule 17a-9 transactions) = 25 hours. 300 hours
+ 250 hours + 25 hours = 575 hours.
    \28\ This estimate is based on the following calculations: (25
fund complexes x $8,021 for revision of procedures concerning stress
testing) = $200,525. (25 fund complexes x $15,490 to provide stress
testing reports) = $387,250. (25 fund complexes x $378 for reporting
of rule 17a-9 transactions) = $9,450. $200,525 + $387,250 + $9,450 =
$597,225.
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    In the rule 2a-7 submissions, Commission staff further estimated
the aggregate annual burdens for registered money market funds that
experience an event of default or insolvency as follows:
    Written record of board determinations and actions related to
failure of a security to meet certain eligibility standards or an event
of default of default or insolvency:

2 responses
1 burden hour of legal time
Cost: $378

    Notice to Commission of an event of default or insolvency:

1 response
0.5 burden hours of legal time
Cost: $189

    Consistent with the estimate in the rule 2a-7 submissions,
Commission staff estimates that approximately 2 percent, or 1,
unregistered money market fund experiences an event of default or
insolvency each year. Accordingly, the staff estimates that one
unregistered money market fund will comply with these collection of
information requirements and engage in 3 annual responses under rule
12d1-1,\29\ the aggregate annual burden hours associated with these
responses is 1.5,\30\ and the aggregate annual cost to funds is
$567.\31\
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    \29\ The estimate is based on the following calculations: (1
fund x 2 responses) + (1 fund x 1 response) = 3 responses.
    \30\ This estimate is based on the following calculations: (1
fund x 1 hour) + (1 fund x 0.5 hours) = 1.5 hours.
    \31\ This estimate is based on the following calculations: (1
fund x $378) + (1 fund x $189) = $567.
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    In the rule 2a-7 submissions, Commission staff further estimated
the aggregate annual burdens for newly registered money market funds as
follows:
    Establish written procedures and guidelines designed to stabilize
the fund's net asset value and establish procedures for board
delegation of authority:

1 response
15.5 hours of director, legal, and support staff time
Cost: $6,328 \32\

    \32\ This estimate is based on the following calculation: (0.5
hours x $4,500 per hour for board time) + (7.2 hours x $378 per hour
for an attorney) + (7.8 hours x $174 per hour for support staff) =
$6,328 per response.
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    Adopt procedures concerning stress testing:

1 response per fund complex
22 burden hours of professional and director time per fund complex
Cost: $19,373 per fund complex \33\

    \33\ This estimate is based on the following calculation: (3
hours x $4,500 per hour for board time) + (8 hours x $378 per hour
for an attorney) + (11 hours x $259 per hour for a risk management
specialist) = $19,373 per response. See also infra note 34.
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    Commission staff estimates that the proportion of unregistered
money market funds that intend to newly undertake the collection of
information burdens of rule 2a-7 will be similar to the proportion of
money market funds that are newly registered. Based on a projection of
10 new money market funds per year (in the most recent rule 2a-7
submission), the staff estimates that, similarly, there will be 10 new
unregistered money market funds that undertake the above burden to
establish written procedures and guidelines designed to stabilize the
fund's net asset value and establish procedures for board delegation of
authority.\34\ Accordingly, the staff estimates that 10 unregistered
money market funds will comply with this collection of information
requirement and engage in 10 annual responses under rule 12d1-1,\35\
the aggregate annual burden hours associated with these responses is
155,\36\ and the aggregate annual cost to funds is $62,380.\37\
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    \34\ The staff's estimate is based on historical data provided
in Lipper Inc.'s LANA database and projections about the growth of
the money market mutual fund industry going forward. The actual
number of new money market funds launched may vary significantly
from our estimates depending upon developments in market interest
rates and reactions to recent amendments adopted to money market
funds in July 2014. The staff does not estimate any new fund
complexes being launched in the next year.
    \35\ The estimate is based on the following calculations: (10
funds x 1 response) = 10 responses.
    \36\ This estimate is based on the following calculations: (10
funds x 15.5 hours) = 155 hours.
    \37\ This estimate is based on the following calculations: (10
funds x $6,238) = $62,380.
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    Accordingly, the estimated total number of annual responses under
rule 12d1-1 for the collections of information described in the rule
2a-7 submissions is 6,950, the aggregate annual burden hours associated
with these responses is 48,479.5, and the aggregate cost to funds is
$14,558,428.\38\
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    \38\ These estimates are based upon the following calculations:
(6,762 + 175 + 3+ 10) = 6,950 annual responses; (47,748 + 575 + 1.5
+ 155) = 48,479.5 burden hours; and ($13,898,256 + $597,225 + $567 +
$62,380) = $14,558,428.
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    Rules 31a-1(b)(1), 31a-1(b)(2)(ii), 31a-1(b)(2)(iv), and 31a-
1(b)(9) require registered funds to keep certain records, which include
journals and general and auxiliary ledgers, including ledgers for each
portfolio security and each shareholder of record of the fund. Most of
the records required to be maintained by the rule are the type that
generally would be maintained as a matter of good business practice and
to prepare the unregistered money market fund's financial statements.
Accordingly, Commission staff estimates that the requirements under
rules 31a-1(b)(1), 31a-1(b)(2)(ii), 31a-1(b)(2)(iv), and 31a-1(b)(9)
would not impose any additional burden because the costs of maintaining
these records would be incurred by unregistered money market funds in
any case to keep books and records that are necessary to prepare
financial statements for shareholders, to prepare the fund's annual
income tax returns, and as a normal business custom.
    Rule 12d1-1 also requires unregistered money market funds in which
registered funds invest to adopt procedures designed to ensure that the
unregistered money market funds comply with sections 17(a), (d), (e),
and 22(e) of the Act. This is a one-time collection of information
requirement that applies to unregistered money market funds that intend
to comply with the requirements of rule 12d1-1. As discussed above,
based on a projection of 10 new money market funds per year, the staff
estimates that, similarly, there will be 10 new unregistered money
market funds that undertake the above burden to establish written
procedures and guidelines designed to ensure that the unregistered
money market funds comply with sections 17(a), (d), (e), and

22(e) of the Act. The staff estimates the burden as follows:
    Establish written procedures and guidelines designed to ensure that
the unregistered money market funds comply with sections 17(a), (d),
(e), and 22(e) of the Act:

1 response
15.5 hours of director, legal, and support staff time
Cost: $6,328 \39\

    \39\ This estimate is based on the following calculation: (0.5
hours x $4,500 per hour for board time) + (7.2 hours x $378 per hour
for an attorney) + (7.8 hours x $174 per hour for support staff) =
$6,328 per response.
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    Accordingly, the staff estimates that 10 unregistered money market
funds will comply with this collection of information requirement and
engage in 10 annual responses under rule 12d1-1,\40\ the aggregate
annual burden hours associated with these responses is 155,\41\ and the
aggregate annual cost to funds is $62,380.\42\
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    \40\ The estimate is based on the following calculations: (10
funds x 1 response) = 10 responses.
    \41\ This estimate is based on the following calculations: (10
funds x 15.5 hours) = 155 hours.
    \42\ This estimate is based on the following calculations: (10
funds x $6,238) = $62,380.
---------------------------------------------------------------------------

    Commission staff also estimates that unregistered money market
funds will incur costs to preserve records, as required under rule 2a-
7. These costs will vary significantly for individual funds, depending
on the amount of assets under fund management and whether the fund
preserves its records in a storage facility in hard copy or has
developed and maintains a computer system to create and preserve
compliance records. In the rule 2a-7 submissions, Commission staff
estimated that the amount an individual money market fund may spend
ranges from $100 per year to $300,000. We have no reason to believe the
range is different for unregistered money market funds. Based on Form
PF data as of May 7, 2014, private liquidity funds have $257 billion in
regulatory assets under management.\43\ The Commission does not have
specific information about the proportion of assets held in small,
medium-sized, or large unregistered money market funds. Because private
liquidity funds are often used as cash management vehicles, the staff
estimates that each private liquidity fund is a ``large'' fund (i.e.,
more than $1 billion in assets under management). Based on a cost of
$0.0000009 per dollar of assets under management (for large funds),\44\
the staff estimates compliance with rule 2-7 for these unregistered
money market funds totals $231,300 annually.\45\
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    \43\ See supra note 12.
    \44\ The recordkeeping cost estimates are $0.0051295 per dollar
of assets under management for small funds, and $0.0005041 per
dollar of assets under management for medium-sized funds. The cost
estimates are the same as those used in the most recently approved
rule 2a-7 submission.
    \45\ This estimate is based on the following calculation: ($257
billion x $0.0000009) = $231,300 billion for small funds.
---------------------------------------------------------------------------

    Consistent with estimates made in the rule 2a-7 submissions,
Commission staff estimates that unregistered money market funds also
incur capital costs to create computer programs for maintaining and
preserving compliance records for rule 2a-7 of $0.0000132 per dollar of
assets under management. Based on the assets under management figures
described above, staff estimates annual capital costs for all
unregistered money market funds of $3.39 million.\46\ Commission staff
further estimates that, even absent the requirements of rule 2a-7,
money market funds would spend at least half of the amounts described
above for record preservation ($115,650) and for capital costs ($1.7
million). Commission staff concludes that the aggregate annual costs of
compliance with the rule are $115,650 for record preservation and $1.7
million for capital costs.
---------------------------------------------------------------------------

    \46\ This estimate is based on the following calculation: ($257
billion x 0.0000132) = $3.39 million.
---------------------------------------------------------------------------

    The collections of information required for unregistered money
market funds by rule 12d1-1 are necessary in order for acquiring funds
to be able to obtain the benefits described above. Notices to the
Commission will not be kept confidential. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send
an email to<EMAIL_ADDRESS>
    Dated: January 16, 2015.
 Brent J. Fields,
 Secretary.
[FR Doc. 2015-01076 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Notices]
[Pages 41031-41032]
[FR Doc No: 2020-14688]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP17-913-004.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Compliance filing NGPL Fuel Transparency Report
Informational Filing.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5153.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-972-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Chevron
911109 Releases eff 07-01-20 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5045.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-973-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Columbia Gas
860005 7-1-2020 releases to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5046.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-974-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 7-1-20 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5053.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-975-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20200630 Negotiated Rate to be
effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5061.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-976-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Filing--Devon Gas Services to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5095.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-977-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amendment to a Negotiated Rate
Agreement Filing-Lucid Energy to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5103.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-978-000.
    Applicants: Cheyenne Connector, LLC.
    Description: Sec.  4(d) Rate Filing: CC 2020-06-30 Administrative
Changes to be effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5109.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-979-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2020-06-30 Administrative
Changes to be effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5112.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-980-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Sec.  4(d) Rate Filing: ETNG Section 4 Rate Case to be
effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5156.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-981-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Limited Section 4 to Adjust
Fuel Gas and Lost and Unaccounted For Retention Fact to be effective 8/
1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5158.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-982-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Atlanta Gas 8438 releases eff 7-1-2020) to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5164.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-983-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Remove Expired Agreements eff
7/1/2020 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5162.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-984-000.
    Applicants: Dominion Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: DETI--June 30, 2020 Negotiated
Rate and Nonconforming Service Agreements to be effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5171.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-985-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Compliance filing Compliance to Settlement in RP20-
177-000 Implement Rates to be effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5176.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-986-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Jul 2020 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5245.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-987-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20200630 Non Conforming to be
effective 7/30/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5290.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-988-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: TETLP EPC AUG 2020 FILING to
be effective 8/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5293.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-989-000.
    Applicants: Texas Eastern Transmission, LP.

    Description: Sec.  4(d) Rate Filing: Negotiated Rates--ConEd 910950
to ENGIE eff 07-01-20 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5363.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-990-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2020-06-30 Non-Conforming
Negotiated Rate Amendment to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5384.
    Comments Due: 5 p.m. ET 7/13/20.

    Docket Numbers: RP20-991-000.
    Applicants: LA Storage, LLC.
    Description: Sec.  4(d) Rate Filing: Filing of Negotiated Rate,
Conforming IW Agreements 7.1.20 to be effective 7/1/2020.
    Filed Date: 6/30/20.
    Accession Number: 20200630-5389.
    Comments Due: 5 p.m. ET 7/13/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 1, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-14688 Filed 7-7-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41184-41185]
[FR Doc No: 2023-13364]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No.: FAA-2023-1264; Summary Notice No. 2023-21]

Petition for Exemption; Summary of Petition Received; Midwest ATC
Service, Inc.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before July 13, 2023.

ADDRESSES: Send comments identified by docket number FAA-2023-1264
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time.

Follow the online instructions for accessing the docket or go to the
Docket Operations in Room W12-140 of the West Building Ground Floor at
1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nia Daniels,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Angela O. Anderson,
Director, Regulatory Support Division, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2023-1264.
    Petitioner: Midwest ATC Service, Inc.
    Section of 14 CFR Affected: Sec.  65.39(a).
    Description of Relief Sought: Midwest ATC Service, Inc. petitions
for relief from 14 CFR 65.39(a) regarding the location of training
under the requirement that an applicant for a facility rating at an air
traffic control contract tower under the FAA Contract Tower Program
must serve as an air traffic control tower operator at that control
tower without a facility rating for at least six months. The petitioner
proposes to allow recent Embry Riddle Aeronautical University (ERAU)
graduates with an Air Traffic Management degree to credit time spent in
a four-month air traffic control classroom and simulation training
program at ERAU towards the six-month on-the-job training requirement
to be eligible for a facility rating.

[FR Doc. 2023-13364 Filed 6-22-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Pages 72744-72745]
[FR Doc No: 2023-23294]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas and Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR24-4-000.
    Applicants: The Peoples Gas Light and Coke Company.
    Description: Sec.  284.123(g) Rate Filing: Petition for Rate
Approval to be effective 11/1/2023.
    Filed Date: 10/16/23.
    Accession Number: 20231016-5092.
    Comment Date: 5 p.m. ET 11/6/23.
    Protest Date: 5 p.m. ET 12/15/23.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission

processes. For public inquiries and assistance with making filings such
as interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: October 16, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-23294 Filed 10-20-23; 8:45 am]
BILLING CODE 6717-01-P