Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 67460-67461 [2011-28240]

Download as PDF 67460 Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Respondents Average burden per response Total annual responses Total hours Interviews Physicians ............................................................................ Advanced practice nurses (NPs) and registered nurses ..... Medical technicians .............................................................. 6 9 9 1 1 1 6 9 9 1 1 1 6 9 9 Subtotal ......................................................................... 24 1 24 1 24 Survey Physicians ............................................................................ Advanced practice nurses (NPs) and registered nurses ..... Medical technicians .............................................................. 120 240 240 1 1 1 120 240 240 .5 .5 .5 60 120 120 Total .............................................................................. ........................ ........................ ........................ ........................ 324 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 26, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28241 Filed 10–31–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0554] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive 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 December 1, 2011. 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 comments should be identified with the OMB control number 0910–0363. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, (301) 796–7651, juanmanuel.vilela@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. ADDRESSES: Veterinary Feed Directive—21 CFR Part 558 (OMB Control Number 0910– 0363)—(Extension) With the passage of the Animal Drug Availability Act of 1996 (ADAA) (Pub. L. 104–250), the Congress enacted legislation establishing a new class of restricted feed use drugs, veterinary feed directive (VFD) drugs, which may be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (21 CFR 558.6) is tailored to the unique circumstances relating to the distribution of medicated feeds. The content of the VFD is spelled out in the regulation. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute, and records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and costeffectively as possible. In the Federal Register of August 3, 2011(76 FR 46818), FDA published a 60day notice requesting public comment on the proposed collection of information. FDA received no comments that pertained to the information collection burden estimates. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents srobinson on DSK4SPTVN1PROD with NOTICES 21 CFR section 558.6(a)(3) through (a)(5) .............................................. 558.6(d)(1)(i) through (d)(1)(iii) ...................................... 558.6(d)(1)(iv) ................................................................ 558.6(d)(2) ..................................................................... 514.1(b)(9) ..................................................................... VerDate Mar<15>2010 19:00 Oct 31, 2011 Jkt 226001 PO 00000 Frm 00059 Number of responses per respondent 15,000 300 20 1,000 1 Fmt 4703 25 1 1 5 1 Sfmt 4703 Total annual responses Average burden per response 375,000 300 20 5,000 1 E:\FR\FM\01NON1.SGM 01NON1 .25 .25 .25 .25 3 Total hours 93,750 75 5 1,250 3 67461 Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR section Total ........................................................................ 1 There Number of responses per respondent Total annual responses Average burden per response ........................ ........................ ........................ .............................. Total hours 95,083 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 558.6(c)(1) through (c)(4) .......................................... 558.6(e)(1) through (e)(4) .......................................... 112,500 5,000 10 75 1,125,000 375,000 .0167 .0167 18,788 6,263 Total .................................................................... ........................ ........................ ........................ .................................. 25,051 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on Agency communication with industry and Agency records and experience. Dated: October 27, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28240 Filed 10–31–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0770] Cosmetic Microbiological Safety Issues; Public Meeting AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments and opening of a docket. ACTION: The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘Cosmetic Microbiological Safety Issues.’’ The purpose of the public meeting is to provide stakeholders an opportunity to present information regarding cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents. FDA is seeking information regarding microbiological testing of cosmetics; types of preservative systems and how to test their efficacy; the identity and prevalence of microorganisms, including antibiotic-resistant strains, that pose specific health risks in finished products; routes of exposure to microorganisms and the corresponding infective doses; product and packaging srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:04 Oct 31, 2011 Jkt 226001 characteristics that affect microbial growth and risk of infection; particular subpopulations that may be at greater risk of infection when using different cosmetic products; the occurrence of adverse events associated with microbial contamination of cosmetics; and any other issues relevant to the microbiological safety of cosmetics. DATES: Submit either electronic or written comments to FDA’s Division of Dockets Management by January 30, 2012. See also ‘‘How to Participate in the Meeting’’ in the SUPPLEMENTARY INFORMATION section of this document for important meeting registration deadlines. ADDRESSES: See Table 1 of this document for meeting location and other information regarding registration for this meeting. FOR FURTHER INFORMATION CONTACT: For questions about registering for the meeting, to register orally, or to submit a notice of participation by mail, fax, or email: Courtney Treece, Planning Professionals, Ltd., 1210 W. McDermott, suite 111, Allen, TX 75013, (704) 258– 4983. Fax: (469) 854–6992, ctreece@planningprofessionals.com. For questions about the meeting, to request an opportunity to make public comments, to submit the full text, comprehensive outline, or summary of an oral presentation, or to request special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, (240) 402–1731, Juanita.Yates@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 and, for products marketed on a retail basis to consumers, under the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1451 et seq.). The law requires that cosmetics be neither adulterated under section 601 of the FD&C Act (21 U.S.C. 361) nor misbranded under section 602 of the FD&C Act (21 U.S.C. 362). That is, they must be safe for consumers under labeled or customary conditions of use and they must be properly labeled. FDA has issued regulations addressing certain aspects of cosmetic safety and labeling (see 21 CFR parts 700, 701, and 740). FDA has also issued guidance regarding certain aspects of cosmetic safety and labeling, including the ‘‘Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist’’ (available at https:// www.fda.gov/Cosmetics/Guidance ComplianceRegulatoryInformation/ GoodManufacturingPracticeGMP GuidelinesInspectionChecklist/ default.htm), the ‘‘Cosmetic Labeling Manual’’ (available at https:// www.fda.gov/Cosmetics/Cosmetic LabelingLabelClaims/CosmeticLabeling Manual/default.htm), and other cosmetic guidance documents (available at https://www.fda.gov/Cosmetics/ GuidanceComplianceRegulatory Information/GuidanceDocuments/ default.htm). FDA has not yet issued specific guidance regarding cosmetic microbiological safety. FDA has presented its preferred laboratory procedures for microbiological analyses of foods and cosmetics in its Bacteriological Analytical Manual (BAM). Chapter 23 of the BAM concerns microbiological methods for cosmetics (available at https://www.fda.gov/Food/ ScienceResearch/LaboratoryMethods/ BacteriologicalAnalyticalManualBAM/ ucm073598.htm). E:\FR\FM\01NON1.SGM 01NON1

Agencies

[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67460-67461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28240]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0554]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Veterinary Feed 
Directive

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 
December 1, 2011.

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 0910-0363. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
juanmanuel.vilela@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.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--(Extension)

    With the passage of the Animal Drug Availability Act of 1996 (ADAA) 
(Pub. L. 104-250), the Congress enacted legislation establishing a new 
class of restricted feed use drugs, veterinary feed directive (VFD) 
drugs, which may be distributed without involving State pharmacy laws. 
Although controls on the distribution and use of VFD drugs are similar 
to those for prescription drugs regulated under section 503(f) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 353(f)), the 
implementing VFD regulation (21 CFR 558.6) is tailored to the unique 
circumstances relating to the distribution of medicated feeds. The 
content of the VFD is spelled out in the regulation. All distributors 
of medicated feed containing VFD drugs must notify FDA of their intent 
to distribute, and records must be maintained of the distribution of 
all medicated feeds containing VFD drugs. The VFD regulation ensures 
the protection of public health while enabling animal producers to 
obtain and use needed drugs as efficiently and cost-effectively as 
possible.
    In the Federal Register of August 3, 2011(76 FR 46818), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments that pertained to 
the information collection burden estimates.
    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
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)...          15,000              25         375,000                .25          93,750
558.6(d)(1)(i) through                    300               1             300                .25              75
 (d)(1)(iii).................
558.6(d)(1)(iv)..............              20               1              20                .25               5
558.6(d)(2)..................           1,000               5           5,000                .25           1,250
514.1(b)(9)..................               1               1               1               3                  3
                              ----------------------------------------------------------------------------------

[[Page 67461]]

 
    Total....................  ..............  ..............  ..............  .................          95,083
----------------------------------------------------------------------------------------------------------------
\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
                           21 CFR section                               Number of      records per    Total annual    Average burden per    Total hours
                                                                      Recordkeepers   recordkeeper       records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4).........................................         112,500              10       1,125,000                .0167          18,788
558.6(e)(1) through (e)(4).........................................           5,000              75         375,000                .0167           6,263
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ..............  ..............  ..............  ...................          25,051
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of the times required for record preparation and 
maintenance is based on Agency communication with industry and Agency 
records and experience.

    Dated: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28240 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.