Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Generic Drug User Fee Act Cover Sheet, 22687-22688 [2014-09201]

Download as PDF Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices For Public Toll Free Telephone: (800) 779–1088 Participant passcode: 4863751 Participant URL: https:// www.mymeetings.com/nc/join/ Purpose: The committee advises the Secretary, Department of Health and Human Services, and the Assistant Secretary for Health in the (a) coordination of all research and education programs and other activities within the Department and with other federal, state, local and private agencies, and (b) establishment and maintenance of liaison with appropriate private entities, federal agencies, and state and local public health agencies with respect to smoking and health activities. Matters For Discussion: The topic of the meeting is ‘‘50 Years of U.S. Tobacco Control’’ and will provide a review of the recently released Surgeon General’s Report on the Health Consequences of Smoking—50 Years of Progress—leading to a discussion of what it will take to end the tobacco epidemic. Agenda items are subject to change as priorities dictate. Contact Person For More Information: Substantive program information as well as summaries of the meeting and roster of committee members may be obtained from the internet at www.cdc.gov/tobacco in midAugust or from Ms. Monica L. Swann, Management and Program Analyst, National Center for Chronic Disease Prevention and Health Promotion, CDC, 395 E. Street SW., Washington, DC 20024, telephone: (202) 245– 0552. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Gary J. Johnson, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2014–09146 Filed 4–22–14; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES wreier-aviles on DSK5TPTVN1PROD with NOTICES [FR Doc. 2014–09148 Filed 4–22–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0079] Food and Drug Administration, HHS. ACTION: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns Conducting Public Health Research in Thailand by the Ministry of Public Health (MOPH), Funding Opportunity Announcement (FOA) GH11–002; Conducting Public Health Research in China, FOA GH12–005, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act Jkt 232001 Gary J. Johnson, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. AGENCY: Centers for Disease Control and Prevention 15:37 Apr 22, 2014 Time and Date: 12:00 p.m.–5:00 p.m., May 14, 2014 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters For Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Conducting Public Health Research in Thailand by the Ministry of Public Health (MOPH), FOA GH11–002; and Conducting Public Health Research in China, FOA GH12–005, initial review.’’ Contact Person For More Information: Hylan Shoob, Scientific Review Officer, Center for Global Health (CGH) Science Office, CGH, CDC, 1600 Clifton Road, NE., Mailstop D–69, Atlanta, Georgia 30033, Telephone: (404) 639–4796. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Generic Drug User Fee Act Cover Sheet BILLING CODE 4163–18–P VerDate Mar<15>2010 (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: 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 May 23, 2014. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 22687 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 0910–0632. 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, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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: Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet—21 U.S.C. 379j–21 (OMB Control Number 0910– 0632)—Revision Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j–21) establishes three different kinds of user fees: (1) Fees for certain types of abbreviated applications for generic new animal drugs, (2) annual fees for certain generic new animal drug products, and (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (21 U.S.C. 379j– 21(a)). Because concurrent submission of user fees with applications is required, the review of an application cannot begin until the fee is submitted. Form FDA 3728 is the Animal Generic Drug User Fee Act (AGDUFA) Cover Sheet, which is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The Animal Generic Drug User Fee Amendments of 2013, signed by the President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113–14), amended the FD&C Act authorizing FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. To implement changes under the reauthorization by their effective date of October 1, 2013, FDA sought and received OMB approval to update its Form FDA 3728 as described as follows: E:\FR\FM\23APN1.SGM 23APN1 22688 Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices On page 1 of the electronic questions under ‘‘Select an Application Type’’ users must select ‘‘Original’’ and then choose either, ‘‘Abbreviated New Animal Drug Application (ANADA)— under provisions of 512(b)(2) of FFDCA [the FD&C Act]’’ (21 U.S.C. 360b(b)(2)); or ‘‘Abbreviated New Animal Drug Application (ANADA)—for certain combination pioneer products approved under provisions of 512(d)(4) of FD&C Act.’’ If they select the first ANADA type, they will be charge 100 percent of the application fee. If they select the second ANADA type, they will be charged at a rate of 50 percent of the original application fee. To facilitate the application process in this regard, on Form FDA 3728 we have added a line in section 3 that allows applicants to select the option, ‘‘3.2 Original Abbreviated New Animal Drug Application (ANADA)—for certain combination pioneer products approved under provisions of section 512(d)(4) of the FD&C Act.’’ In the Federal Register of February 18, 2014 (79 FR 9224), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA form No. Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 3728 ......................................................... 20 2 40 .08 (4.8 minutes) ........................ 3.2 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to this collection of information are generic animal drug applicants. Based on data for the past 3 years, FDA estimates there are approximately 20 submissions annually and a total of 3.2 burden hours. Dated: April 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09201 Filed 4–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0252] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping 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 May 23, 2014. 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: wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:37 Apr 22, 2014 Jkt 232001 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0216. 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, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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. Color Additive Certification Requests and Recordkeeping—21 CFR Part 80 (OMB Control Number 0910–0216)— Extension We have regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(a)) provides that a color additive shall be deemed to be unsafe unless it meets the requirements of a listing regulation, including any requirement for batch certification, and is used in accordance with the regulation. We list color additives that have been shown to be safe for their intended uses in Title 21 of the Code of Federal Regulations (CFR). We require batch certification for all color additives listed in 21 CFR part 74 and for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80. In the certification procedure, a representative sample of a new batch of PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 color additive, accompanied by a ‘‘request for certification’’ that provides information about the batch, must be submitted to FDA’s Office of Cosmetics and Colors. FDA personnel perform chemical and other analyses of the representative sample and, providing the sample satisfies all certification requirements, issue a certification lot number for the batch. We charge a fee for certification based on the batch weight and require manufacturers to keep records of the batch pending and after certification. Under § 80.21, a request for certification must include: Name of color additive, manufacturer’s batch number and weight in pounds, name and address of manufacturer, storage conditions, statement of use(s), certification fee, and signature of person requesting certification. Under § 80.22, a request for certification must include a sample of the batch of color additive that is the subject of the request. The sample must be labeled to show: Name of color additive, manufacturer’s batch number and quantity, and name and address of person requesting certification. Under § 80.39, the person to whom a certificate is issued must keep complete records showing the disposal of all of the color additive covered by the certificate. Such records are to be made available upon request to any accredited representative of FDA until at least 2 years after disposal of all of the color additive. The purpose for collecting this information is to help us assure that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States. The required information is unique to the batch of color additive that is the subject of a request for certification. The E:\FR\FM\23APN1.SGM 23APN1

Agencies

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22687-22688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0079]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Generic Drug 
User Fee Act Cover Sheet

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 May 23, 
2014.

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 0910-0632. 
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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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.

Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C. 
379j-21 (OMB Control Number 0910-0632)--Revision

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 379j-21) establishes three different kinds of user 
fees: (1) Fees for certain types of abbreviated applications for 
generic new animal drugs, (2) annual fees for certain generic new 
animal drug products, and (3) annual fees for certain sponsors of 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs (21 U.S.C. 
379j-21(a)). Because concurrent submission of user fees with 
applications is required, the review of an application cannot begin 
until the fee is submitted. Form FDA 3728 is the Animal Generic Drug 
User Fee Act (AGDUFA) Cover Sheet, which is designed to provide the 
minimum necessary information to determine whether a fee is required 
for review of an application, to determine the amount of the fee 
required, and to account for and track user fees.
    The Animal Generic Drug User Fee Amendments of 2013, signed by the 
President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113-14), 
amended the FD&C Act authorizing FDA to collect user fees for certain 
abbreviated applications for generic new animal drugs, for certain 
generic new animal drug products, and for certain sponsors of such 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs. To implement 
changes under the reauthorization by their effective date of October 1, 
2013, FDA sought and received OMB approval to update its Form FDA 3728 
as described as follows:

[[Page 22688]]

    On page 1 of the electronic questions under ``Select an Application 
Type'' users must select ``Original'' and then choose either, 
``Abbreviated New Animal Drug Application (ANADA)--under provisions of 
512(b)(2) of FFDCA [the FD&C Act]'' (21 U.S.C. 360b(b)(2)); or 
``Abbreviated New Animal Drug Application (ANADA)--for certain 
combination pioneer products approved under provisions of 512(d)(4) of 
FD&C Act.'' If they select the first ANADA type, they will be charge 
100 percent of the application fee. If they select the second ANADA 
type, they will be charged at a rate of 50 percent of the original 
application fee. To facilitate the application process in this regard, 
on Form FDA 3728 we have added a line in section 3 that allows 
applicants to select the option, ``3.2 Original Abbreviated New Animal 
Drug Application (ANADA)--for certain combination pioneer products 
approved under provisions of section 512(d)(4) of the FD&C Act.''
    In the Federal Register of February 18, 2014 (79 FR 9224), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
                  FDA form No.                      Number of      responses per     Total annual       Average burden per response        Total hours
                                                   respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728...........................................              20                2               40   .08 (4.8 minutes)..................             3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are generic animal 
drug applicants. Based on data for the past 3 years, FDA estimates 
there are approximately 20 submissions annually and a total of 3.2 
burden hours.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09201 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P
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