Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application, 3735-3736 [2010-1154]

Download as PDF Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices Gordon Fisher, Office of the Assistant Secretary for Planning and Evaluation, Room 404E, Humphrey Building, Department of Health and Human Services, Washington, DC 20201— telephone: (202) 690–7507—or visit https://aspe.hhs.gov/poverty/. For information about the percentage multiple of the poverty guidelines to be used on immigration forms such as USCIS Form I–864, Affidavit of Support, contact U.S. Citizenship and Immigration Services at 1–800–375– 5283. For information about the Hill-Burton Uncompensated Services Program (free or reduced-fee health care services at certain hospitals and other facilities for persons meeting eligibility criteria involving the poverty guidelines), contact the Office of the Director, Division of Facilities Compliance and Recovery, Health Resources and Services Administration, HHS, Room 10–105, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. To speak to a staff member, please call (301) 443–5656. To receive a Hill-Burton information package, call 1– 800–638–0742 (for callers outside Maryland) or 1–800–492–0359 (for callers in Maryland). You also may visit https://www.hrsa.gov/hillburton/ default.htm. For information about the number of people in poverty, visit the Poverty section of the Census Bureau’s Web site at https://www.census.gov/hhes/www/ poverty/poverty.html or contact the Census Bureau’s Demographic Call Center Staff at (301) 763–2422 or 1–866– 758–1060 (toll-free). SUPPLEMENTARY INFORMATION: Under authority of section 1012 of the Department of Defense Appropriations Act, 2010 (Pub. L. 111–118), the HHS poverty guidelines that were published in the Federal Register (74 FR 4199) on January 23, 2009, shall remain in effect until the Secretary of Health and Human Services publishes updated poverty guidelines for 2010, which shall not take place before March 1, 2010. The 2009 poverty guideline figures which shall remain in effect are given below. 2009 POVERTY GUIDELINES FOR THE 48 CONTIGUOUS STATES AND THE DISTRICT OF COLUMBIA erowe on DSK5CLS3C1PROD with NOTICES Persons in family 1 2 3 4 5 6 7 VerDate Nov<24>2008 2009 POVERTY GUIDELINES FOR THE SUMMARY: The Food and Drug 48 CONTIGUOUS STATES AND THE Administration (FDA) is announcing DISTRICT OF COLUMBIA—Continued that a proposed collection of Persons in family Poverty guideline 8 ...................................... 37,010 For families with more than 8 persons, add $3,740 for each additional person. 2009 POVERTY GUIDELINES FOR ALASKA Persons in family 1 2 3 4 5 6 7 8 Poverty guideline ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... $13,530 18,210 22,890 27,570 32,250 36,930 41,610 46,290 For families with more than 8 persons, add $4,680 for each additional person. 2009 POVERTY GUIDELINES FOR HAWAII Persons in family 1 2 3 4 5 6 7 8 Poverty guideline ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... $12,460 16,760 21,060 25,360 29,660 33,960 38,260 42,560 For families with more than 8 persons, add $4,300 for each additional person. Dated: January 19, 2010. Kathleen Sebelius, Secretary of Health and Human Services. [FR Doc. 2010–1234 Filed 1–21–10; 8:45 am] BILLING CODE 4151–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0511] Agency Information Collection Activities; Submission for Office of Management and Budget Review; $10,830 Comment Request; Medicated Feed 14,570 Mill License Application Poverty guideline ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... 14:43 Jan 21, 2010 18,310 22,050 25,790 29,530 33,270 Jkt 220001 3735 AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00040 Fmt 4703 Sfmt 4703 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 February 22, 2010. 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0337. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. 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. Medicated Feed Mill License Application—(OMB Control No. 0910– 0337)—Extension The Animal Drug Availability Act (ADAA) of October 9, 1996, amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) to replace the system for the approval of specific medicated feed with a general licensing system for feed mills. Before passage of the ADAA, medicated feed manufacturers were required to obtain approval of Medicated Feed Applications (MFAs), in order to manufacture certain types of medicated feeds. An individual approved MFA was required for each and every applicable medicated feed. The ADAA streamlined the paperwork process for gaining approval to manufacture medicated feeds by replacing the MFA system with a facility license for each medicated feed manufacturing facility. In the Federal Register of October 28, 2009 (74 FR 55556), 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: E:\FR\FM\22JAN1.SGM 22JAN1 3736 Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 515.10(b) 20 1 20 0.25 515.11(b) 75 1 75 0.25 18.75 515.23 40 1 40 0.25 10 515.30(c) 0.15 1 0.15 24 Total Burden Hours 1 There 5 3.6 37.35 are no capital costs or maintenance costs associated with this information collection. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 510.305 1 There 1,000 Total Annual Records 1 Hours per Recordkeeper 1,000 0.03 Total Hours 30 are no capital costs or maintenance costs associated with this information collection. The estimated annual reporting burden on industry is 37.35 hours as shown in table 1 of this document. Industry estimates it takes about 1/4 hour to submit the application. We estimate 135 original and supplemental applications, and voluntary revocations for a total of 33.75 hours (135 submissions x 1/4 hour). An additional 3.6 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 30 hours for maintaining and retrieving labels as required by 21 CFR 510.305 and shown in table 2 of this document. We estimated .03 hours for each of approximately 1,000 licensees. Thus, the total annual burden for reporting and recordkeeping requirements is estimated be 67.35 hours. Dated: January 15, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–1154 Filed 1–21–10; 8:45 am] BILLING CODE 4160–01–S erowe on DSK5CLS3C1PROD with NOTICES Annual Frequency per Recordkeeping DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–10–0017] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Application for Training (OMB No. 0920–0017 Exp. 3/31/2010)— Extension—Office of Workforce and Career Development (OWCD), Centers for Disease Control and Prevention (CDC). Background and Brief Description OWCD requests an additional three years to continue CDC’s and the Agency for Toxic Substances and Disease Registry’s (ATSDR’s) use of the training application forms 32.1 and 36.5 (50,000 students × 5 minutes for form 32.1, and VerDate Nov<24>2008 14:43 Jan 21, 2010 Jkt 220001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 24,000 students × 5 minutes for form 36.5). These instruments have served and are proposed to continue serving as official training applications forms used for training activities conducted by the Centers for Disease Control and Prevention (CDC). CDC offers public health training activities to professionals worldwide. Employees of hospitals, universities, medical centers, laboratories, State and Federal agencies, and State and local health departments apply for training to learn up-to-date public health practices. CDC’s training activities include laboratory training, classroom study, online training, and distance learning. CDC uses training application forms to collect information necessary to manage and conduct training pertinent to the agency’s mission. This information allows CDC to send confirmation of registration to participants, provide certificates of attendance or continuing education credits as proof of participants’ attendance, and generate management reports to identify training needs, design courses, select location for courses, and evaluate programs. Since the previous approval, there have been no changes to the information collection instruments; however, the number of annual responses has increased, simultaneously increasing burden hours. There are no costs to the respondents other than their time. The total estimated annualized burden is 6,167 hours. E:\FR\FM\22JAN1.SGM 22JAN1

Agencies

[Federal Register Volume 75, Number 14 (Friday, January 22, 2010)]
[Notices]
[Pages 3735-3736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1154]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medicated Feed Mill 
License Application

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 
February 22, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0337. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Medicated Feed Mill License Application--(OMB Control No. 0910-0337)--
Extension

    The Animal Drug Availability Act (ADAA) of October 9, 1996, amended 
section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360b) to replace the system for the approval of specific 
medicated feed with a general licensing system for feed mills. Before 
passage of the ADAA, medicated feed manufacturers were required to 
obtain approval of Medicated Feed Applications (MFAs), in order to 
manufacture certain types of medicated feeds. An individual approved 
MFA was required for each and every applicable medicated feed. The ADAA 
streamlined the paperwork process for gaining approval to manufacture 
medicated feeds by replacing the MFA system with a facility license for 
each medicated feed manufacturing facility.
    In the Federal Register of October 28, 2009 (74 FR 55556), 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:

[[Page 3736]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.10(b)                                                           20                        1              20                  0.25               5
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.11(b)                                                           75                        1              75                  0.25              18.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.23                                                              40                        1              40                  0.25              10
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.30(c)                                                            0.15                     1               0.15              24                  3.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden Hours                                                                                                                                 37.35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this information collection.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510.305                                                             1,000                     1              1,000               0.03                 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this information collection.

    The estimated annual reporting burden on industry is 37.35 hours as 
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 135 original and 
supplemental applications, and voluntary revocations for a total of 
33.75 hours (135 submissions x 1/4 hour). An additional 3.6 hours is 
added for the rare notice of opportunity for a hearing to not approve 
or revoke an application. Finally, we estimate 30 hours for maintaining 
and retrieving labels as required by 21 CFR 510.305 and shown in table 
2 of this document. We estimated .03 hours for each of approximately 
1,000 licensees. Thus, the total annual burden for reporting and 
recordkeeping requirements is estimated be 67.35 hours.

    Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1154 Filed 1-21-10; 8:45 am]
BILLING CODE 4160-01-S
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