Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species, 39734-39736 [2013-15792]

Download as PDF 39734 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURES 1—Continued Number of respondents Activity/21 CFR section Total .......................................................... Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 2 ........................ ........................ ........................ ........................ 3,691,842 Total operating & maintenance costs 24,259,921 1 There are no capital costs associated with this collection of information. 2 Total hours have been rounded. 3 Refers to the facility component of the burden for this requirement. 4 Refers to the AB component of the burden for this requirement. 5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. Dated: June 25, 2013. Leslie Kux, Assistant Commissioner for Policy. Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15790 Filed 7–1–13; 8:45 am] [FR Doc. 2013–15795 Filed 7–1–13; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2013–N–0033] [Docket No. FDA–2012–N–1108] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Interstate Shellfish Dealer’s Certificate AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Interstate Shellfish Dealer’s Certificate’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 25, 2013, the Agency submitted a proposed collection of information entitled, ‘‘Interstate Shellfish Dealer’s Certificate’’ to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0021. The approval expires on May 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. VerDate Mar<15>2010 17:51 Jul 01, 2013 Food and Drug Administration, HHS. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water Jkt 229001 ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 26, 2013, the Agency submitted a proposed collection of information entitled ‘‘Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water’’ to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0658. The approval expires on May 31, 2016. A SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15793 Filed 7–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0716] Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the paperwork associated with designation under the Minor Use and Minor Species (MUMS) Act. DATES: Submit either electronic or written comments on the collection of information by September 3, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug SUMMARY: E:\FR\FM\02JYN1.SGM 02JYN1 39735 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400T, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Designated New Animal Drugs for Minor Use and Minor Species—21 CFR Part 516 (OMB Control Number 0910– 0605)—Extension Description: The Minor Use and Minor Species (MUMS) Animal Health Act of 2004 amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. This legislation provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing limited-demand animal drugs. These incentives are only available to sponsors whose drugs are ‘‘MUMS-designated’’ by FDA. Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of animals either because they occur infrequently or in limited geographic areas. Minor species are all animals other than the major species; for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include animals such as sheep, goats, catfish, and honeybees. Participation in the MUMS program is completely optional for drug sponsors so the associated paperwork only applies to those sponsors who request and are subsequently granted ‘‘MUMS designation.’’ The rule specifies the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees. Section 516.20 (21 CFR 516.20) provides requirements on the content and format of a request for MUMS-drug designation; § 516.26 (21 CFR 516.26) provides requirements for amending MUMS-drug designation; provisions for change in sponsorship of MUMS-drug designation can be found under § 516.27 (21 CFR 516.27); under § 516.29 (21 CFR 516.29) are provisions for termination of MUMS-drug designation; under § 516.30 (21 CFR 516.30) are requirements for annual reports from sponsor(s) of MUMS-designated drugs; and under § 516.36 (21 CFR 516.36) are provisions for insufficient quantities of MUMSdesignated drugs. Description of Respondents: Pharmaceutical companies that sponsor new animal drugs. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section 516.20; 516.26; 516.27; 516.29; 516.30; 516.36; Number of responses per respondent Total annual responses Average burden per response Total hours tkelley on DSK3SPTVN1PROD with NOTICES 15 3 1 2 15 1 5 1 1 1 5 1 75 3 1 2 75 1 16 2 1 1 2 3 1200 6 1 2 150 3 Total .............................................................................. 1 content and format of MUMS request .................... requirements for amending MUMS designation ..... change in sponsorship ............................................ termination of MUMS designation .......................... requirements for annual reports ............................. insufficient quantities .............................................. ........................ ........................ ........................ ........................ 1,362 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 16:48 Jul 01, 2013 Jkt 229001 PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\02JYN1.SGM 02JYN1 39736 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices The burden estimate for this reporting requirement was derived in our Office of Minor Use and Minor Species Animal Drug Development by extrapolating the current investigational new animal drug/new animal drug application reporting requirements for similar actions by this same segment of the regulated industry and from previous interactions with the minor use/minor species community. Dated: June 25, 2013. Leslie Kux, Assistant Commissioner for Policy. Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15794 Filed 7–1–13; 8:45 am] Food and Drug Administration BILLING CODE 4160–01–P [Docket No. FDA–2013–D–0576] DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft Guidance for Industry: Considerations for the Design of EarlyPhase Clinical Trials of Cellular and Gene Therapy Products; Availability Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: [Docket No. FDA–2013–N–0032] HHS. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Labeling; Notification Procedures for Statements on Dietary Supplements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 27, 2013, the Agency submitted a proposed collection of information entitled ‘‘Food Labeling; Notification Procedures for Statements on Dietary Supplements’’ to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0331. The approval expires on May 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/ Processors With Interest in Exporting to Chile BILLING CODE 4160–01–P VerDate Mar<15>2010 16:48 Jul 01, 2013 Jkt 229001 ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/ Processors With Interest in Exporting to Chile’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 25, 2013, the Agency submitted a proposed collection of information entitled, ‘‘Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile’’ to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0509. The approval expires on May 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUMMARY: Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15796 Filed 7–1–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. [Docket No. FDA–2012–N–1106] [FR Doc. 2013–15792 Filed 7–1–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ‘‘Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products’’ dated July 2013. The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 22, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUMMARY: E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39734-39736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15792]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0716]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Designated New Animal Drugs for Minor Use and Minor
Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the paperwork associated with
designation under the Minor Use and Minor Species (MUMS) Act.

DATES: Submit either electronic or written comments on the collection
of information by September 3, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug

[[Page 39735]]

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Designated New Animal Drugs for Minor Use and Minor Species--21 CFR
Part 516 (OMB Control Number 0910-0605)--Extension

Description: The Minor Use and Minor Species (MUMS) Animal Health
Act of 2004 amended the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) to authorize FDA to establish new regulatory procedures intended
to make more medications legally available to veterinarians and animal
owners for the treatment of minor animal species as well as uncommon
diseases in major animal species. This legislation provides incentives
designed to help pharmaceutical companies overcome the financial
burdens they face in providing limited-demand animal drugs. These
incentives are only available to sponsors whose drugs are ``MUMS-
designated'' by FDA. Minor use drugs are drugs for use in major species
(cattle, horses, swine, chickens, turkeys, dogs, and cats) that are
needed for diseases that occur in only a small number of animals either
because they occur infrequently or in limited geographic areas. Minor
species are all animals other than the major species; for example, zoo
animals, ornamental fish, parrots, ferrets, and guinea pigs. Some
animals of agricultural importance are also minor species. These
include animals such as sheep, goats, catfish, and honeybees.
Participation in the MUMS program is completely optional for drug
sponsors so the associated paperwork only applies to those sponsors who
request and are subsequently granted ``MUMS designation.'' The rule
specifies the criteria and procedures for requesting MUMS designation
as well as the annual reporting requirements for MUMS designees.
Section 516.20 (21 CFR 516.20) provides requirements on the content
and format of a request for MUMS-drug designation; Sec. 516.26 (21 CFR
516.26) provides requirements for amending MUMS-drug designation;
provisions for change in sponsorship of MUMS-drug designation can be
found under Sec. 516.27 (21 CFR 516.27); under Sec. 516.29 (21 CFR
516.29) are provisions for termination of MUMS-drug designation; under
Sec. 516.30 (21 CFR 516.30) are requirements for annual reports from
sponsor(s) of MUMS-designated drugs; and under Sec. 516.36 (21 CFR
516.36) are provisions for insufficient quantities of MUMS-designated
drugs.
Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs.
FDA estimates the burden of this collection of information 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
----------------------------------------------------------------------------------------------------------------
516.20; content and format of 15 5 75 16 1200
MUMS request...................
516.26; requirements for 3 1 3 2 6
amending MUMS designation......
516.27; change in sponsorship... 1 1 1 1 1
516.29; termination of MUMS 2 1 2 1 2
designation....................
516.30; requirements for annual 15 5 75 2 150
reports........................
516.36; insufficient quantities. 1 1 1 3 3
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Total....................... .............. .............. .............. .............. 1,362
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 39736]]

The burden estimate for this reporting requirement was derived in
our Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug/new animal
drug application reporting requirements for similar actions by this
same segment of the regulated industry and from previous interactions
with the minor use/minor species community.

Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15792 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P

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