81 FR 22619 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 74 (April 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 74 (April 18, 2016)
| Page Range | 22619-22620 | |
| FR Document | 2016-08893 |
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)] [Notices] [Pages 22619-22620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08893] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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
![Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices 22619
‘‘burden’’ under 5 CFR 1320.3(b)(2). prescription orders under the orders for identified individual patients
FDA understands that maintaining enforcement policy described in section during the reference period that the
records of prescriptions for III.B.2 of this guidance and section licensed pharmacist or licensed
compounded drug products is part of 503A(a)(2) of the FD&C Act. These physician selected (i.e., a 30-day period
the usual course of the practice of records should clearly reflect the within the last year).
compounding and selling drugs and is quantity of a particular drug product We estimate that annually a total of
required by States’ pharmacy laws and compounded in advance of receiving approximately 10,332 licensed
other State laws governing record prescription orders for identified pharmacists and licensed physicians
keeping by health care professionals and individual patients that the compounder (‘‘number of recordkeepers’’ in table 2)
health care facilities. has kept on hand as stock for will maintain approximately 103,320
Under the guidance, licensed distribution, and the basis for the records (‘‘total annual records’’ in table
pharmacists and licensed physicians quantity the compounder kept in stock. 2). We estimate that maintaining the
should also maintain records of the Under the enforcement policy described records will take approximately 5
calculations performed to determine the in section III.B.2 of this guidance, this minutes per record.
limited quantities of drug products would include the quantity of the drug FDA estimates the burden of this
compounded before the receipt of valid product distributed under prescription collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Type of reporting disclosures per burden per Total hours
respondents disclosures
respondent disclosure
Consultation between the licensed pharmacist or licensed 3,444 50 172,200 0.083 (5 min- 14,350
physician and the prescriber and adding a notation to doc- utes).
ument the prescriber’s determination that a compounded
drug is necessary for an identified patient.
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 Number of Average
Total annual
Type of reporting record- records per burden per Total hours
records
keepers recordkeeper recordkeeping
Records of calculations performed to determine ‘‘limited 10,332 10 103,320 0.083 (5 min- 8,610
quantities’’. utes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access ACTION: Notice. Spring, MD 20993–0002, PRAStaff@
Persons with access to the Internet fda.hhs.gov.
SUMMARY: The Food and Drug
may obtain the draft guidance at either Administration (FDA) is announcing SUPPLEMENTARY INFORMATION: In
http://www.fda.gov/Drugs/Guidance that a proposed collection of compliance with 44 U.S.C. 3507, FDA
ComplianceRegulatoryInformation/ information has been submitted to the has submitted the following proposed
Guidances/default.htm or http:// Office of Management and Budget collection of information to OMB for
www.regulations.gov. (OMB) for review and clearance under review and clearance.
Dated: April 12, 2016. the Paperwork Reduction Act of 1995. Inspection by Accredited Persons
Leslie Kux, DATES: Fax written comments on the Program Under the Medical Device
Associate Commissioner for Policy. collection of information by May 18, User Fee and Modernization Act of
[FR Doc. 2016–08877 Filed 4–15–16; 8:45 am] 2016. 2002—OMB Control Number 0910–
BILLING CODE 4164–01–P ADDRESSES: To ensure that comments on 0510—Extension
the information collection are received, The Medical Device User Fee and
OMB recommends that written Modernization Act of 2002 (MDUFMA)
DEPARTMENT OF HEALTH AND comments be faxed to the Office of
HUMAN SERVICES (Pub. L. 107–250) was signed into law
Information and Regulatory Affairs, on October 26, 2002. Section 201 of
OMB, Attn: FDA Desk Officer, FAX: MDUFMA added a new paragraph (g) to
Food and Drug Administration
202–395–7285, or emailed to oira_ section 704 of the Federal, Food, Drug,
[Docket No. FDA–2012–N–0427] submission@omb.eop.gov. All and Cosmetic Act (21 U.S.C. 374),
comments should be identified with the directing FDA to accredit third parties
Agency Information Collection OMB control number 0910–0510. Also
mstockstill on DSK4VPTVN1PROD with NOTICES
Activities; Submission for Office of (accredited persons) to conduct
include the FDA docket number found inspections of eligible manufacturers of
Management and Budget Review; in brackets in the heading of this
Comment Request; Medical Devices; class II or class III devices. FDA’s
document. guidance document entitled
Inspection by Accredited Persons
Program FOR FURTHER INFORMATION CONTACT: FDA ‘‘Implementation of the Inspection by
PRA Staff, Office of Operations, Food Accredited Persons Program Under the
AGENCY: Food and Drug Administration, and Drug Administration, 8455 Medical Device User Fee and
HHS. Colesville Rd., COLE–14526, Silver Modernization Act of 2002;
VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/81_FR_22693/page/1.svg)
![22620 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
Accreditation Criteria’’ provides In the Federal Register of October 21, information. No comments were
information for those interested in 2015 (80 FR 63806), FDA published a received.
participating in this voluntary program. 60-day notice requesting public FDA estimates the burden of this
comment on the proposed collection of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent 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. 5630 Fishers Lane, Rm. 1061, Rockville, II. Description of Tobacco Farm Site
Leslie Kux, MD 20852. Tours Program
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: In the Tobacco Farm Site Tours
[FR Doc. 2016–08893 Filed 4–15–16; 8:45 am] Allison Hoffman, Office of Science, Program, small groups of CTP staff plan
BILLING CODE 4164–01–P Center for Tobacco Products, Food and to observe the operations of farms that
Drug Administration, 10903 New grow tobacco for sale to tobacco product
Hampshire Ave., Bldg. 75, Rm. 5426, manufacturers. Please note that FDA
DEPARTMENT OF HEALTH AND Silver Spring, MD 20993–0002, 1–877– does not regulate these farms and the
HUMAN SERVICES 287–1373, email: CTPRegulations@ Tobacco Farm Site Tours Program is not
fda.hhs.gov. an inspection of facilities to determine
Food and Drug Administration
SUPPLEMENTARY INFORMATION: compliance with the FD&C Act; rather,
this program is meant to educate CTP
[Docket No. FDA–2016–N–1109] I. Background staff and improve their understanding of
On June 22, 2009, the President tobacco farming. It is anticipated that
Tobacco Farm Site Tours Program
signed the Family Smoking Prevention the tobacco farm site tours will take
AGENCY: Food and Drug Administration, and Tobacco Control Act (Pub. L. 111– place in the fall of 2016.
HHS. 31) into law, amending the Federal III. Site Selection
ACTION: Notice. Food, Drug, and Cosmetic Act (the
FD&C Act) and giving FDA authority to CTP hopes to be able to tour small,
SUMMARY: The Food and Drug regulate tobacco product manufacturing, medium, and large farms, and farms that
Administration (FDA), Center for distribution, and marketing. grow tobacco for different kinds of
Tobacco Products (CTP), is announcing tobacco products. Final site selections
CTP’s Office of Science is conducting
an invitation for participation in its will be based on the availability of
the Tobacco Farm Site Tours Program to
voluntary Tobacco Farm Site Tours funds and resources for the relevant
provide its staff an opportunity to visit
Program. This program is intended to fiscal year as well as the desire to visit
farms that grow tobacco for sale to
give CTP staff an opportunity to visit a wide variety of types of tobacco farms.
tobacco product manufacturers (a
farms that grow tobacco for sale to FDA plans on visiting nine or fewer
‘‘tobacco product manufacturer’’ is
tobacco product manufacturers in order farms. All FDA travel expenses
defined as any person, including any
to gain a better understanding of tobacco associated with the farm site tours will
repacker or relabeler, who
farming and the processes involved in be the responsibility of FDA.
manufactures, fabricates, assembles,
curing and preparing tobacco intended processes, or labels a tobacco product, IV. Requests for Participation
for sale to tobacco product or imports a finished tobacco product
manufacturers. This program is not an To aid in site selection, your request
for sale or distribution in the United
FDA regulatory inspection, and tobacco for participation should include the
States (section 900(20) of the FD&C Act
farms are not regulated entities unless following information:
(21 U.S.C. 387(20))). Although farms
they are also a tobacco product that grow tobacco are not FDA-regulated • A description of your farm,
manufacturer or controlled by a tobacco entities unless they are also a tobacco including the size of the farm;
product manufacturer. The purpose of product manufacturer or controlled by a • A list of the type(s) of tobacco
this notice is to invite parties interested tobacco product manufacturer (see grown and the kinds of tobacco product
in participating in the Tobacco Farm section 901(c)(2) of the FD&C Act (21 manufacturers to whom you sell
Site Tours Program to submit requests to U.S.C. 387a(c)(2))), tobacco farm site tobacco;
CTP. visits will aid the Agency in gaining a • The physical address(es) of the
DATES: Submit either an electronic or better understanding of tobacco farming site(s) for which you are submitting a
written request for participation in this and the processes involved in curing request; and
program by June 17, 2016. See section and preparing tobacco leaf intended for • A proposed 1-day tour agenda.
IV of this document for information on
mstockstill on DSK4VPTVN1PROD with NOTICES
sale to tobacco product manufacturers. Identify requests for participation
requests for participation. The goal for the Tobacco Farm Site with the docket number found in
ADDRESSES: If your farm is interested in Tours Program is for CTP staff to gain brackets in the heading of this
offering a site visit, please submit a firsthand exposure to tobacco farming document. Received requests are
request either electronically to http:// practices, including cultivation, available for public examination in the
www.regulations.gov or in writing to the harvesting, curing, and preparation for Division of Dockets Management (see
Division of Dockets Management (HFA– sale of tobacco leaf to tobacco product ADDRESSES) between 9 a.m. and 4 p.m.,
305), Food and Drug Administration, manufacturers. Monday through Friday.
VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/81_FR_22693/page/2.svg)
Document Created: 2016-04-16 01:45:44
Document Modified: 2016-04-16 01:45:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 18, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 22619 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR