81 FR 44875 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 132 (July 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44875-44876 | |
| FR Document | 2016-16349 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Notices] [Pages 44875-44876] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16349] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-N-0221; FDA-2012-N-0559; FDA-2015-N-3287; FDA- 2015-N-3815; FDA-2007-D-0429; FDA-2012-N-0447; FDA-2011-D-0597; FDA- 2011-D-0164; FDA-2013-N-0013; FDA-2011-N-0146; FDA-2014-N-1533; FDA- 2011-N-0921; FDA-2015-N-2163] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Food Labeling: Notification Procedures 0910-0331 6/30/2019 for Statements on Dietary Supplements.. PHS Guideline on Infectious Disease 0910-0456 6/30/2019 Issues in Xenotransplantation.......... MDUFMA Small Business Qualification 0910-0508 6/30/2019 Certification.......................... Electronic Submission of Medical Device 0910-0625 6/30/2019 Registration and Listing............... Guidance for Industry on Q & A Regarding 0910-0641 6/30/2019 Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act................ Antimicrobial Animal Drug Distribution 0910-0659 6/30/2019 Reports and Recordkeeping.............. Guidance for Industry on Oversight of 0910-0733 6/30/2019 Clinical Investigations: A Risk-Based Approach to Monitoring................. Guidance for Industry on Safety Labeling 0910-0734 6/30/2019 Changes; Implementation of the Federal Food, Drug, and Cosmetic Act........... Accreditation of Third Party 0910-0750 6/30/2019 Certification Bodies to Conduct Food Safety Audits and Issue Certifications. Sanitary Transportation of Human and 0910-0773 6/30/2019 Animal Food............................ National Panel of Tobacco Consumer 0910-0815 6/30/2019 Studies................................ Standards for the Growing, Harvesting, 0910-0816 6/30/2019 Packaging, and Holding of Produce for Human Consumption...................... Hearing, Aging, and Direct-to-Consumer 0910-0818 6/30/2019 Television Advertisements.............. ------------------------------------------------------------------------ Dated: July 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16349 Filed 7-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44875
Health guidance documents is available information in 21 CFR part 814, subpart ACTION: Notice.
at http://www.fda.gov/MedicalDevices/ H have been approved under OMB
DeviceRegulationandGuidance/ control number 0910–0332. The SUMMARY: The Food and Drug
GuidanceDocuments/default.htm. collections of information in the Administration (FDA) is publishing a
Guidance documents are also available guidance document ‘‘Guidance for HDE list of information collections that have
at http://www.regulations.gov. Persons Holders, Institutional Review Boards been approved by the Office of
unable to download an electronic copy (IRBs), Clinical Investigators, and FDA Management and Budget (OMB) under
of ‘‘Information to Support a Claim of Staff—Humanitarian Device Exemption
the Paperwork Reduction Act of 1995.
Electromagnetic Compatibility (EMC) of (HDE) Regulation: Questions and
Electrically-Powered Medical Device’’ Answers’’ have been approved under FOR FURTHER INFORMATION CONTACT: FDA
may send an email request to CDRH- OMB control number 0910–0661. PRA Staff, Office of Operations, Food
Guidance@fda.hhs.gov to receive an Dated: July 5, 2016. and Drug Administration, Three White
electronic copy of the document. Please Leslie Kux, Flint North 10A63, 11601 Landsdown
use the document number 1400057 to Associate Commissioner for Policy. St., North Bethesda, MD 20852,
identify the guidance you are [FR Doc. 2016–16350 Filed 7–8–16; 8:45 am] PRAStaff@fda.hhs.gov.
requesting.
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: The
IV. Paperwork Reduction Act of 1995 following is a list of FDA information
collections recently approved by OMB
This guidance refers to previously DEPARTMENT OF HEALTH AND
under section 3507 of the Paperwork
approved collections of information HUMAN SERVICES
Reduction Act of 1995 (44 U.S.C. 3507).
found in FDA regulations. These
Food and Drug Administration The OMB control number and
collections of information are subject to
expiration date of OMB approval for
review by the Office of Management and [Docket Nos. FDA–2009–N–0221; FDA–
Budget (OMB) under the Paperwork each information collection are shown
2012–N–0559; FDA–2015–N–3287; FDA–
Reduction Act of 1995 (44 U.S.C. 3501– in table 1. Copies of the supporting
2015–N–3815; FDA–2007–D–0429; FDA–
3520). The collections of information in 2012–N–0447; FDA–2011–D–0597; FDA– statements for the information
21 CFR part 814 have been approved 2011–D–0164; FDA–2013–N–0013; FDA– collections are available on the Internet
under OMB control number 0910–0231. 2011–N–0146; FDA–2014–N–1533; FDA– at http://www.reginfo.gov/public/do/
The collections of information in 21 2011–N–0921; FDA–2015–N–2163] PRAMain. An Agency may not conduct
CFR part 807, subpart E have been or sponsor, and a person is not required
Agency Information Collection to respond to, a collection of
approved under OMB control number
Activities; Announcement of Office of information unless it displays a
0910–0120. The collections of
Management and Budget Approvals
information in 21 CFR part 812 have currently valid OMB control number.
been approved under OMB control AGENCY: Food and Drug Administration,
number 0910–0078. The collections of HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Food Labeling: Notification Procedures for Statements on Dietary Supplements .................................................. 0910–0331 6/30/2019
PHS Guideline on Infectious Disease Issues in Xenotransplantation .................................................................... 0910–0456 6/30/2019
MDUFMA Small Business Qualification Certification .............................................................................................. 0910–0508 6/30/2019
Electronic Submission of Medical Device Registration and Listing ........................................................................ 0910–0625 6/30/2019
Guidance for Industry on Q & A Regarding Labeling of Nonprescription Human Drug Products Marketed With-
out an Approved Application as Required by the Dietary Supplement & Nonprescription Drug Consumer
Protection Act ....................................................................................................................................................... 0910–0641 6/30/2019
Antimicrobial Animal Drug Distribution Reports and Recordkeeping ...................................................................... 0910–0659 6/30/2019
Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring ................. 0910–0733 6/30/2019
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic
Act ........................................................................................................................................................................ 0910–0734 6/30/2019
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ........... 0910–0750 6/30/2019
Sanitary Transportation of Human and Animal Food .............................................................................................. 0910–0773 6/30/2019
National Panel of Tobacco Consumer Studies ....................................................................................................... 0910–0815 6/30/2019
Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption ............... 0910–0816 6/30/2019
Hearing, Aging, and Direct-to-Consumer Television Advertisements ..................................................................... 0910–0818 6/30/2019
Dated: July 6, 2016.
Leslie Kux,
sradovich on DSK3GDR082PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2016–16349 Filed 7–8–16; 8:45 am]
BILLING CODE 4164–01–P
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![44876 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
DEPARTMENT OF HEALTH AND the Federal Food, Drug, and Cosmetic with USP 32 Chapter 823, and that FDA
HUMAN SERVICES Act (the FD&C Act) regarding safety, should estimate the recordkeeping
identity, strength, quality, and purity. burden under USP 32 Chapter 823.
Food and Drug Administration The CGMP requirements for PET drugs
(Response) FDA agrees with the
are issued under the provisions of the
[Docket No. FDA–2013–N–0242] comment that facilities incur a burden
Food and Drug Administration
Modernization Act of 1997 (the to comply with USP 32 Chapter 823.
Agency Information Collection However, compliance with USP
Activities; Submission for Office of Modernization Act). These CGMP
requirements are designed to take into provisions is beyond the scope of this
Management and Budget Review; information collection, which only
Comment Request; Current Good account the unique characteristics of
PET drugs, including their short half- pertains to the requirements under part
Manufacturing Practice for Positron
lives, and the fact that most PET drugs 212.
Emission Tomography Drugs
are produced at locations that are very (Comment 3) The comment said FDA
AGENCY: Food and Drug Administration, close to the patients to whom the drugs ‘‘averages’’ the burden across different
HHS. are administered. categories of respondents and responses,
ACTION: Notice. The CGMP regulations are intended to and that this approach results in lower
ensure that approved PET drugs meet burden estimates. For example, the
SUMMARY: The Food and Drug the requirements of the FD&C Act as to
comment said that most recordkeeping
Administration (FDA) is announcing safety, identity, strength, quality, and
will continue to be with a paper-based
that a proposed collection of purity. The regulations address the
information has been submitted to the following matters: Personnel and system and not an electronic system,
Office of Management and Budget resources; quality assurance; facilities and that the costs are different for each
(OMB) for review and clearance under and equipment; control of components, system. In addition, there are
the Paperwork Reduction Act of 1995. in-process materials, and finished differences between the costs incurred
products; production and process by commercial and academic facilities.
DATES: Fax written comments on the
collection of information by August 10, controls; laboratory controls; acceptance (Response) All commercial PET drug
2016. criteria; labeling and packaging controls; facilities are currently utilizing
distribution controls; complaint electronic records for recordkeeping as
ADDRESSES: To ensure that comments on
handling; and recordkeeping. well as paper-based records.
the information collection are received,
The CGMP regulations establish Commercial PET drug manufacturers
OMB recommends that written
several recordkeeping requirements and
comments be faxed to the Office of comprise approximately 90 percent of
a third-party disclosure requirement for
Information and Regulatory Affairs, the manufacturing sites. Many academic
the production of PET drugs. In making
OMB, Attn: FDA Desk Officer, FAX: PET facilities still use paper-based
our estimates of the time spent in
202–395–7285, or emailed to oira_ complying with these information records. However, academic PET sites
submission@omb.eop.gov. All collection requirements, we relied on produce fewer batches for clinical use
comments should be identified with the informal communications we have had compared to commercial sites, and have
OMB control number 0910–0667 and with PET producers, visits by our staff fewer records. Sufficient resources and
title ‘‘Current Good Manufacturing to PET facilities, and our familiarity personnel are needed to perform the
Practice for Positron Emission with both PET and general PET drug production activities, and
Tomography Drugs.’’ Also include the pharmaceutical manufacturing academic PET drug sites limited in
FDA docket number found in brackets practices. personnel and resources do bear more of
in the heading of this document. In the Federal Register of December the regulatory burden. After a firm’s
FOR FURTHER INFORMATION CONTACT: FDA 29, 2015 (80 FR 81332), FDA published recordkeeping process is established,
PRA Staff, Office of Operations, Food a 60-day notice requesting public the burdens are generally the same for
and Drug Administration, Three White comment on the proposed collection of entering records into an electronic
Flint North 10A63, 11601 Landsdown information and the estimated annual system or a paper-based system. We
St., North Bethesda, MD 20852, burden for recordkeeping and third question whether it is worthwhile to
PRAStaff@fda.hhs.gov. party disclosure. In response to the prepare separate estimates for
SUPPLEMENTARY INFORMATION: In notice, FDA received several comments. commercial versus academic sites
compliance with 44 U.S.C. 3507, FDA The comments raised a number of issues because academic sites are a small
has submitted the following proposed that are discussed as follows. percentage of the total. Also, providing
collection of information to OMB for (Comment 1) The comment disagreed an average estimate is consistent with
review and clearance. with FDA’s estimate that 129 PET drug
PRA requirements and, based on our
production facilities are required to
Current Good Manufacturing Practice calculations, the number of academic
comply with part 212. Based on its
for Positron Emission Tomography records, the comment said that sites that apply for drug applications
Drugs OMB Control Number 0910– approximately 150 facilities are subject represents a small percentage.
0667—Extension to the PET CGMP requirements. (Comment 4) The comment
Positron emission tomography is a (Response) We have revised the questioned FDA’s methodology for
medical imaging modality involving the burden estimates to account for 150 PET determining the burden estimates,
sradovich on DSK3GDR082PROD with NOTICES
use of a unique type of drug production facilities. especially in table 2 where the actual
radiopharmaceutical drug product. (Comment 2) The comment disagreed burden may be underestimated ‘‘by a
FDA’s Current Good Manufacturing with FDA’s statement in section I of the factor of 10 to 100.’’
Practice (CGMP) regulations at 21 CFR December 29, 2015, Federal Register
part 212 are intended to ensure that notice, ‘‘Investigational and Research (Response) In estimating the time to
positron emission tomography (PET) PET Drugs.’’ The comment said that PET comply with these information
drug products meet the requirements of facilities devote resources to comply collection requirements, we relied on
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Document Created: 2016-07-09 00:21:29
Document Modified: 2016-07-09 00:21:29
| 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. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 44875 |
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