Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Uses, 35956-35957 [2015-15320]
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35956
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
proprietary loans, this would meet the
PRA’s definition of paperwork burden.
There are also additional provisions
in the guidance that apply to both
proprietary and HECM reverse
mortgages that do not meet the ‘‘usual
and customary’’ standard, are not
covered by already approved
information collections and, therefore,
likewise meet the PRA’s definition of
paperwork burden.
mstockstill on DSK4VPTVN1PROD with NOTICES
Proprietary Reverse Mortgages
Financial institutions offering
proprietary reverse mortgages are
encouraged under the guidance to
follow or adopt relevant HECM
requirements for mandatory counseling,
disclosures, affordable origination fees,
restrictions on cross-selling of ancillary
products, and reliable appraisals.
Proprietary and HECM Reverse
Mortgages
Financial institutions offering either
proprietary or HECM reverse mortgages
are encouraged to develop clear and
balanced product descriptions and make
them available to consumers shopping
for a mortgage. They should set forth a
description of how disbursements can
be received and include timely
information to supplement disclosures
mandated by TILA and other
disclosures. Promotional materials and
product descriptions should include
information about the costs, terms,
features, and risks of reverse mortgage
products.
Financial institutions should adopt
policies and procedures that prohibit
directing a consumer to a particular
counseling agency or contacting a
counselor on the consumer’s behalf.
They should adopt clear written policies
and establish internal controls
specifying that neither the lender nor
any broker will require the borrower to
purchase any other product from the
lender in order to obtain the mortgage.
Policies should be clear so that
originators do not have an inappropriate
incentive to sell other products that
appear linked to the granting of a
mortgage. Legal and compliance reviews
should include oversight of
compensation programs so that lending
personnel are not improperly
encouraged to direct consumers to
particular products.
Financial institutions making,
purchasing, or servicing reverse
mortgages through a third party should
conduct due diligence and establish
criteria for third-party relationships and
compensation. They should set
requirements for agreements and
establish systems to monitor compliance
with the agreement and applicable laws
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
and regulations. They should also take
corrective action if a third party fails to
comply. Third-party relationships
should be structured in a way that does
not conflict with RESPA.
Board of Governors of the Federal Reserve
System, June 18, 2015.
Robert deV. Frierson,
Secretary of the Board.
[FR Doc. 2015–15412 Filed 6–22–15; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0481]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Investigational Uses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by July 23,
2015.
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 0910–0117. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
New Animal Drugs for Investigational
Uses—21 CFR Part 511
OMB Control Number 0910–0117—
Extension
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to approve new animal
drugs. Section 512(j) of the FD&C Act
(21 U.S.C. 360b(j)) authorizes FDA to
issue regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
part 511. If the new animal drug is only
for tests in vitro or in laboratory
research animals, the person
distributing the new animal drug must
maintain records showing the name and
post office address of the expert or
expert organization to whom it is
shipped and the date, quantity, and
batch or code mark of each shipment
and delivery for a period of 2 years after
such shipment or delivery. Before
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
Identity of the new animal drug, (2)
labeling, (3) statement of compliance of
any non-clinical laboratory studies with
good laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
information regarding the use of edible
tissues from investigational animals.
Part 511 also requires that records be
established and maintained to
document the distribution and use of
the investigational new animal drug to
assure that its use is safe, and that the
distribution is controlled to prevent
potential abuse. The Agency uses these
required records under its Bioresearch
Monitoring Program to monitor the
validity of the studies submitted to FDA
to support new animal drug approval
and to assure that proper use of the drug
is maintained by the investigator.
Investigational new animal drugs are
used primarily by drug industry firms,
academic institutions, and the
government. Investigators may include
individuals from these entities, as well
as research firms and members of the
medical professions. Respondents to
this collection of information are the
persons who use new animal drugs for
investigational purposes.
In the Federal Register of April 2,
2015 (80 FR 17758), FDA published a
60-day notice requesting public
comment on the proposed collection of
E:\FR\FM\23JNN1.SGM
23JNN1
35957
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
information. Two comments were
received but neither responded to any of
the four information collection topics
solicited and are therefore not addressed
by the Agency.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
511.1(b)(4) .......................................................
511.1(b)(5) .......................................................
511.1(b)(6) .......................................................
511.1(b)(8)(ii) ...................................................
511.1(b)(9) .......................................................
263
263
263
263
263
5.30
.26
.01
.06
.06
1,395
69
2
15
15
1
8
1
2
8
1,395
552
2
30
120
Total ..........................................................
............................
............................
............................
............................
2,099
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of records
per
recordkeeper
Total annual
records
Average burden
per
recordkeeping
Total hours
511.1(a)(3) .................................................
511.1(b)(3) .................................................
511.1(b)(7)(ii) .............................................
511.1(b)(8)(i) ..............................................
263
263
263
263
2.07
5.30
5.30
5.30
545
1,395
1,395
1,395
1
1
3.5
3.5
545
1,395
4,882.5
4,882.5
Total ....................................................
..............................
..............................
............................
..............................
11,705
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on
informal Agency communication with
industry. Based on the number of
sponsors subject to animal drug user
fees, FDA estimates that there are 263
respondents. We use this estimate
consistently throughout the table and
calculate the ‘‘annual frequency per
respondent’’ by dividing the total
annual responses by number of
respondents. Additional information
needed to make a final calculation of the
total burden hours (i.e., the number of
respondents, the number of
recordkeepers, the number of NCIEs
received, etc.) is derived from Agency
records.
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15320 Filed 6–22–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
and Recordkeeping Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 22,
2015.
SUMMARY:
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
ADDRESSES:
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
comments should be identified with the
OMB control number 0910–0230. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Postmarketing Adverse Drug
Experience Reporting
OMB Control Number 0910–0230—
(Extension)
Sections 201, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 352, 355, and 371)
require that marketed drugs be safe and
effective. In order to know whether
drugs that are not safe and effective are
on the market, FDA must be promptly
informed of adverse experiences
associated with the use of marketed
drugs. In order to help ensure this, FDA
issued regulations at §§ 310.305 and
314.80 (21 CFR 310.305 and 314.80) to
impose reporting and recordkeeping
requirements on the drug industry that
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35956-35957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15320]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0481]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs for
Investigational Uses
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 July
23, 2015.
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 0910-0117.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
New Animal Drugs for Investigational Uses--21 CFR Part 511
OMB Control Number 0910-0117--Extension
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the
FD&C Act (21 U.S.C. 360b(j)) authorizes FDA to issue regulations
relating to the investigational use of new animal drugs. The
regulations setting forth the conditions for investigational use of new
animal drugs have been codified at part 511. If the new animal drug is
only for tests in vitro or in laboratory research animals, the person
distributing the new animal drug must maintain records showing the name
and post office address of the expert or expert organization to whom it
is shipped and the date, quantity, and batch or code mark of each
shipment and delivery for a period of 2 years after such shipment or
delivery. Before shipping a new animal drug for clinical investigations
in animals, a sponsor must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The NCIE must contain, among other
things, the following specific information: (1) Identity of the new
animal drug, (2) labeling, (3) statement of compliance of any non-
clinical laboratory studies with good laboratory practices, (4) name
and address of each clinical investigator, (5) the approximate number
of animals to be treated or amount of new animal drug(s) to be shipped,
and (6) information regarding the use of edible tissues from
investigational animals. Part 511 also requires that records be
established and maintained to document the distribution and use of the
investigational new animal drug to assure that its use is safe, and
that the distribution is controlled to prevent potential abuse. The
Agency uses these required records under its Bioresearch Monitoring
Program to monitor the validity of the studies submitted to FDA to
support new animal drug approval and to assure that proper use of the
drug is maintained by the investigator.
Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities, as well as
research firms and members of the medical professions. Respondents to
this collection of information are the persons who use new animal drugs
for investigational purposes.
In the Federal Register of April 2, 2015 (80 FR 17758), FDA
published a 60-day notice requesting public comment on the proposed
collection of
[[Page 35957]]
information. Two comments were received but neither responded to any of
the four information collection topics solicited and are therefore not
addressed by the Agency.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
511.1(b)(4)................................................... 263 5.30 1,395 1 1,395
511.1(b)(5)................................................... 263 .26 69 8 552
511.1(b)(6)................................................... 263 .01 2 1 2
511.1(b)(8)(ii)............................................... 263 .06 15 2 30
511.1(b)(9)................................................... 263 .06 15 8 120
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 2,099
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
511.1(a)(3)................................................ 263 2.07 545 1 545
511.1(b)(3)................................................ 263 5.30 1,395 1 1,395
511.1(b)(7)(ii)............................................ 263 5.30 1,395 3.5 4,882.5
511.1(b)(8)(i)............................................. 263 5.30 1,395 3.5 4,882.5
--------------------------------------------------------------------------------------------
Total.................................................. ................. ................. ................ ................. 11,705
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on informal Agency communication with industry. Based on the
number of sponsors subject to animal drug user fees, FDA estimates that
there are 263 respondents. We use this estimate consistently throughout
the table and calculate the ``annual frequency per respondent'' by
dividing the total annual responses by number of respondents.
Additional information needed to make a final calculation of the total
burden hours (i.e., the number of respondents, the number of
recordkeepers, the number of NCIEs received, etc.) is derived from
Agency records.
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15320 Filed 6-22-15; 8:45 am]
BILLING CODE 4164-01-P
