Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 22619-22620 [2016-08893]

Download as PDF Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices ‘‘burden’’ under 5 CFR 1320.3(b)(2). FDA understands that maintaining records of prescriptions for compounded drug products is part of the usual course of the practice of compounding and selling drugs and is required by States’ pharmacy laws and other State laws governing record keeping by health care professionals and health care facilities. Under the guidance, licensed pharmacists and licensed physicians should also maintain records of the calculations performed to determine the limited quantities of drug products compounded before the receipt of valid prescription orders under the enforcement policy described in section III.B.2 of this guidance and section 503A(a)(2) of the FD&C Act. These records should clearly reflect the quantity of a particular drug product compounded in advance of receiving prescription orders for identified individual patients that the compounder has kept on hand as stock for distribution, and the basis for the quantity the compounder kept in stock. Under the enforcement policy described in section III.B.2 of this guidance, this would include the quantity of the drug product distributed under prescription 22619 orders for identified individual patients during the reference period that the licensed pharmacist or licensed physician selected (i.e., a 30-day period within the last year). We estimate that annually a total of approximately 10,332 licensed pharmacists and licensed physicians (‘‘number of recordkeepers’’ in table 2) will maintain approximately 103,320 records (‘‘total annual records’’ in table 2). We estimate that maintaining the records will take approximately 5 minutes per record. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents Type of reporting Consultation between the licensed pharmacist or licensed physician and the prescriber and adding a notation to document the prescriber’s determination that a compounded drug is necessary for an identified patient. 1 There Number of disclosures per respondent 3,444 50 Total annual disclosures 172,200 Average burden per disclosure 0.083 (5 minutes). Total hours 14,350 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 Type of reporting Records of calculations performed to determine ‘‘limited quantities’’. 1 There Number of records per recordkeeper 10,332 10 Total annual records 103,320 Average burden per recordkeeping Total hours 0.083 (5 minutes). 8,610 are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access ACTION: Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Notice. SUMMARY: Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. [FR Doc. 2016–08877 Filed 4–15–16; 8:45 am] 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 18, 2016. BILLING CODE 4164–01–P ADDRESSES: Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002—OMB Control Number 0910– 0510—Extension FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107–250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA’s guidance document entitled ‘‘Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2012–N–0427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 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 0910–0510. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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: E:\FR\FM\18APN1.SGM 18APN1 22620 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices Accreditation Criteria’’ provides information for those interested in participating in this voluntary program. In the Federal Register of October 21, 2015 (80 FR 63806), 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 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Request for accreditation ..................................................... 1 1 1 80 80 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Office of Science, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 5426, Silver Spring, MD 20993–0002, 1–877– 287–1373, email: CTPRegulations@ fda.hhs.gov. [FR Doc. 2016–08893 Filed 4–15–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration SUPPLEMENTARY INFORMATION: [Docket No. FDA–2016–N–1109] I. Background Tobacco Farm Site Tours Program On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111– 31) into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. CTP’s Office of Science is conducting the Tobacco Farm Site Tours Program to provide its staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers (a ‘‘tobacco product manufacturer’’ is defined as any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished tobacco product for sale or distribution in the United States (section 900(20) of the FD&C Act (21 U.S.C. 387(20))). Although farms that grow tobacco are not FDA-regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer (see section 901(c)(2) of the FD&C Act (21 U.S.C. 387a(c)(2))), tobacco farm site visits will aid the Agency in gaining a better understanding of tobacco farming and the processes involved in curing and preparing tobacco leaf intended for sale to tobacco product manufacturers. The goal for the Tobacco Farm Site Tours Program is for CTP staff to gain firsthand exposure to tobacco farming practices, including cultivation, harvesting, curing, and preparation for sale of tobacco leaf to tobacco product manufacturers. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP. DATES: Submit either an electronic or written request for participation in this program by June 17, 2016. See section IV of this document for information on requests for participation. ADDRESSES: If your farm is interested in offering a site visit, please submit a request either electronically to https:// www.regulations.gov or in writing to the Division of Dockets Management (HFA– 305), Food and Drug Administration, mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 II. Description of Tobacco Farm Site Tours Program In the Tobacco Farm Site Tours Program, small groups of CTP staff plan to observe the operations of farms that grow tobacco for sale to tobacco product manufacturers. Please note that FDA does not regulate these farms and the Tobacco Farm Site Tours Program is not an inspection of facilities to determine compliance with the FD&C Act; rather, this program is meant to educate CTP staff and improve their understanding of tobacco farming. It is anticipated that the tobacco farm site tours will take place in the fall of 2016. III. Site Selection CTP hopes to be able to tour small, medium, and large farms, and farms that grow tobacco for different kinds of tobacco products. Final site selections will be based on the availability of funds and resources for the relevant fiscal year as well as the desire to visit a wide variety of types of tobacco farms. FDA plans on visiting nine or fewer farms. All FDA travel expenses associated with the farm site tours will be the responsibility of FDA. IV. Requests for Participation To aid in site selection, your request for participation should include the following information: • A description of your farm, including the size of the farm; • A list of the type(s) of tobacco grown and the kinds of tobacco product manufacturers to whom you sell tobacco; • The physical address(es) of the site(s) for which you are submitting a request; and • A proposed 1-day tour agenda. Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22619-22620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0427]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Inspection by Accredited Persons Program

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 18, 
2016.

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 0910-0510. 
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, 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.

Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002--OMB Control Number 0910-0510--
Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 
of MDUFMA added a new paragraph (g) to section 704 of the Federal, 
Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit 
third parties (accredited persons) to conduct inspections of eligible 
manufacturers of class II or class III devices. FDA's guidance document 
entitled ``Implementation of the Inspection by Accredited Persons 
Program Under the Medical Device User Fee and Modernization Act of 
2002;

[[Page 22620]]

Accreditation Criteria'' provides information for those interested in 
participating in this voluntary program.
    In the Federal Register of October 21, 2015 (80 FR 63806), 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
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for accreditation..........................................               1                1                1               80               80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08893 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P
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