80 FR 35956 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Uses
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 120 (June 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 120 (June 23, 2015)
| Page Range | 35956-35957 | |
| FR Document | 2015-15320 |
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)] [Notices] [Pages 35956-35957] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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
![35956 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
proprietary loans, this would meet the and regulations. They should also take New Animal Drugs for Investigational
PRA’s definition of paperwork burden. corrective action if a third party fails to Uses—21 CFR Part 511
There are also additional provisions comply. Third-party relationships OMB Control Number 0910–0117—
in the guidance that apply to both should be structured in a way that does Extension
proprietary and HECM reverse not conflict with RESPA.
mortgages that do not meet the ‘‘usual FDA has the authority under the
Board of Governors of the Federal Reserve Federal Food, Drug, and Cosmetic Act
and customary’’ standard, are not System, June 18, 2015.
covered by already approved (the FD&C Act) to approve new animal
Robert deV. Frierson, drugs. Section 512(j) of the FD&C Act
information collections and, therefore,
Secretary of the Board. (21 U.S.C. 360b(j)) authorizes FDA to
likewise meet the PRA’s definition of
paperwork burden. [FR Doc. 2015–15412 Filed 6–22–15; 8:45 am] issue regulations relating to the
BILLING CODE 6210–01–P investigational use of new animal drugs.
Proprietary Reverse Mortgages The regulations setting forth the
Financial institutions offering conditions for investigational use of
proprietary reverse mortgages are new animal drugs have been codified at
encouraged under the guidance to DEPARTMENT OF HEALTH AND part 511. If the new animal drug is only
follow or adopt relevant HECM HUMAN SERVICES for tests in vitro or in laboratory
requirements for mandatory counseling, research animals, the person
disclosures, affordable origination fees, Food and Drug Administration distributing the new animal drug must
restrictions on cross-selling of ancillary maintain records showing the name and
products, and reliable appraisals. [Docket No. FDA–2011–N–0481] post office address of the expert or
expert organization to whom it is
Proprietary and HECM Reverse Agency Information Collection shipped and the date, quantity, and
Mortgages Activities; Submission for Office of batch or code mark of each shipment
Financial institutions offering either Management and Budget Review; and delivery for a period of 2 years after
proprietary or HECM reverse mortgages Comment Request; New Animal Drugs such shipment or delivery. Before
are encouraged to develop clear and for Investigational Uses shipping a new animal drug for clinical
balanced product descriptions and make investigations in animals, a sponsor
them available to consumers shopping AGENCY: Food and Drug Administration, must submit to FDA a Notice of Claimed
for a mortgage. They should set forth a HHS. Investigational Exemption (NCIE). The
description of how disbursements can ACTION: Notice. NCIE must contain, among other things,
be received and include timely the following specific information: (1)
information to supplement disclosures SUMMARY: The Food and Drug Identity of the new animal drug, (2)
mandated by TILA and other Administration (FDA) is announcing labeling, (3) statement of compliance of
disclosures. Promotional materials and that a proposed collection of any non-clinical laboratory studies with
product descriptions should include information has been submitted to the good laboratory practices, (4) name and
information about the costs, terms, Office of Management and Budget address of each clinical investigator, (5)
features, and risks of reverse mortgage (OMB) for review and clearance under the approximate number of animals to
products. the Paperwork Reduction Act of 1995. be treated or amount of new animal
Financial institutions should adopt drug(s) to be shipped, and (6)
policies and procedures that prohibit DATES: Fax written comments on the information regarding the use of edible
directing a consumer to a particular collection of information by July 23, tissues from investigational animals.
counseling agency or contacting a 2015. Part 511 also requires that records be
counselor on the consumer’s behalf. established and maintained to
They should adopt clear written policies ADDRESSES: To ensure that comments on
document the distribution and use of
and establish internal controls the information collection are received,
the investigational new animal drug to
specifying that neither the lender nor OMB recommends that written
assure that its use is safe, and that the
any broker will require the borrower to comments be faxed to the Office of
distribution is controlled to prevent
purchase any other product from the Information and Regulatory Affairs,
potential abuse. The Agency uses these
lender in order to obtain the mortgage. OMB, Attn: FDA Desk Officer, FAX:
required records under its Bioresearch
Policies should be clear so that 202–395–7285, or emailed to oira_
Monitoring Program to monitor the
originators do not have an inappropriate submission@omb.eop.gov. All
validity of the studies submitted to FDA
incentive to sell other products that comments should be identified with the
to support new animal drug approval
appear linked to the granting of a OMB control number 0910–0117. Also
and to assure that proper use of the drug
mortgage. Legal and compliance reviews include the FDA docket number found
is maintained by the investigator.
should include oversight of in brackets in the heading of this Investigational new animal drugs are
compensation programs so that lending document. used primarily by drug industry firms,
personnel are not improperly FOR FURTHER INFORMATION CONTACT: FDA academic institutions, and the
encouraged to direct consumers to PRA Staff, Office of Operations, Food government. Investigators may include
particular products. and Drug Administration, 8455 individuals from these entities, as well
Financial institutions making, Colesville Rd., COLE–14526, Silver as research firms and members of the
mstockstill on DSK4VPTVN1PROD with NOTICES
purchasing, or servicing reverse Spring, MD 20993–0002, PRAStaff@ medical professions. Respondents to
mortgages through a third party should fda.hhs.gov. this collection of information are the
conduct due diligence and establish persons who use new animal drugs for
criteria for third-party relationships and SUPPLEMENTARY INFORMATION: In investigational purposes.
compensation. They should set compliance with 44 U.S.C. 3507, FDA In the Federal Register of April 2,
requirements for agreements and has submitted the following proposed 2015 (80 FR 17758), FDA published a
establish systems to monitor compliance collection of information to OMB for 60-day notice requesting public
with the agreement and applicable laws review and clearance. comment on the proposed collection of
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![Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices 35957
information. Two comments were solicited and are therefore not addressed FDA estimates the burden of this
received but neither responded to any of by the Agency. information collection as follows:
the four information collection topics
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
21 CFR section responses per Total hours
respondents responses per response
respondent
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 records Average burden
Number of Total annual
21 CFR section per per Total hours
recordkeepers records
recordkeeper recordkeeping
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 DEPARTMENT OF HEALTH AND comments should be identified with the
reporting requirements, record HUMAN SERVICES OMB control number 0910–0230. Also
preparation, and maintenance for this include the FDA docket number found
collection of information is based on Food and Drug Administration in brackets in the heading of this
informal Agency communication with document.
[Docket No. FDA–2012–N–0253]
industry. Based on the number of FOR FURTHER INFORMATION CONTACT: FDA
sponsors subject to animal drug user Agency Information Collection PRA Staff, Office of Operations, Food
fees, FDA estimates that there are 263 Activities; Submission for Office of and Drug Administration, 8455
respondents. We use this estimate Management and Budget Review; Colesville Rd., COLE–14526, Silver
consistently throughout the table and Comment Request; Postmarketing Spring, MD 20993–0002,
calculate the ‘‘annual frequency per Adverse Drug Experience Reporting PRAStaff@fda.hhs.gov.
respondent’’ by dividing the total and Recordkeeping Biological
Products SUPPLEMENTARY INFORMATION: In
annual responses by number of
compliance with 44 U.S.C. 3507, FDA
respondents. Additional information AGENCY: Food and Drug Administration, has submitted the following proposed
needed to make a final calculation of the HHS. collection of information to OMB for
total burden hours (i.e., the number of review and clearance.
ACTION: Notice.
respondents, the number of
recordkeepers, the number of NCIEs SUMMARY: The Food and Drug Postmarketing Adverse Drug
received, etc.) is derived from Agency Administration (FDA) is announcing Experience Reporting
records. that a proposed collection of OMB Control Number 0910–0230—
Dated: June 17, 2015. information has been submitted to the (Extension)
Office of Management and Budget
Leslie Kux, Sections 201, 502, 505, and 701 of the
(OMB) for review and clearance under
Associate Commissioner for Policy. the Paperwork Reduction Act of 1995. Federal Food, Drug, and Cosmetic Act
[FR Doc. 2015–15320 Filed 6–22–15; 8:45 am] (21 U.S.C. 321, 352, 355, and 371)
DATES: Fax written comments on the
BILLING CODE 4164–01–P
require that marketed drugs be safe and
collection of information by July 22, effective. In order to know whether
2015. drugs that are not safe and effective are
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDRESSES: To ensure that comments on on the market, FDA must be promptly
the information collection are received, informed of adverse experiences
OMB recommends that written associated with the use of marketed
comments be faxed to the Office of drugs. In order to help ensure this, FDA
Information and Regulatory Affairs, issued regulations at §§ 310.305 and
OMB, Attn: FDA Desk Officer, FAX: 314.80 (21 CFR 310.305 and 314.80) to
202–395–7285, or emailed to impose reporting and recordkeeping
oira_submission@omb.eop.gov. All requirements on the drug industry that
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Document Created: 2018-02-22 11:15:37
Document Modified: 2018-02-22 11:15:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by July 23, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 35956 |
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