80 FR 35366 - Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 118 (June 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 118 (June 19, 2015)
| Page Range | 35366-35367 | |
| FR Document | 2015-15076 |
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)] [Notices] [Pages 35366-35367] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15076] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1434] Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Debra Catterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-3861; or Vilayat Sayeed, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-9077. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' FDA is concerned that the differences in size, shape, and other physical characteristics between a generic drug and the originator drug may affect patient compliance and acceptability of medication regimens or could lead to medication errors. For example, studies show that tablet size and shape can affect ease of swallowing; generic tablets that are significantly larger than their corresponding reference drug product may be more difficult to swallow, leading to potential adverse events as well as noncompliance with treatment regimens. FDA is recommending that generic manufacturers consider the size, shape, and other physical characteristics of the originator drug when developing a generic version. In the Federal Register of December 10, 2013 (78 FR 74154), this guidance was published as a draft guidance. We have carefully reviewed and considered the comments that were received on the draft guidance and have made editorial changes primarily for clarification. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the size, shape, and other physical attributes of generic tablets and capsules. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. [[Page 35367]] II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information requested in the guidance is covered under FDA regulations at 21 CFR part 314 and approved under OMB control number 0910-0001. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15076 Filed 6-18-15; 8:45 am] BILLING CODE 4164-01-P
![35366 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
To obtain copies of a supporting facilities for participation, and by State 0002. Send one self-addressed adhesive
statement and any related forms for the Medicaid agencies, which have label to assist that office in processing
proposed collection(s) summarized in comparable authority under Medicaid. your requests. See the SUPPLEMENTARY
this notice, you may make your request The information on the Hospice Survey INFORMATION section for electronic
using one of following: and Deficiencies Report Form is coded access to the guidance document.
1. Access CMS’ Web site address at for entry into the OSCAR system. The Submit electronic comments on the
http://www.cms.hhs.gov/ data is analyzed by the CMS regional guidance to http://www.regulations.gov.
PaperworkReductionActof1995. offices and by the CMS central office Submit written comments to the
2. Email your request, including your components for program evaluation and Division of Dockets Management (HFA–
address, phone number, OMB number, monitoring purposes. The information is 305), Food and Drug Administration,
and CMS document identifier, to also available to the public upon 5630 Fishers Lane, Rm. 1061, Rockville,
Paperwork@cms.hhs.gov. request. Form Number: CMS–643 (OMB MD 20852.
3. Call the Reports Clearance Office at control number: 0938–0379); Frequency: FOR FURTHER INFORMATION CONTACT:
(410) 786–1326. Yearly; Affected Public: State, Local, or Debra Catterson, Center for Drug
FOR FURTHER INFORMATION CONTACT: Tribal Governments; Number of Evaluation and Research, Food and
Reports Clearance Office at (410) 786– Respondents: 3,976; Total Annual Drug Administration, 10903 New
1326. Responses: 1,325; Total Annual Hours: Hampshire Ave., Silver Spring, MD
1,325. (For policy questions regarding 20993–0002, 240–402–3861; or Vilayat
SUPPLEMENTARY INFORMATION:
this collection contact Annette Snyder Sayeed, Center for Drug Evaluation and
Contents at 410–786–0807.) Research, Food and Drug
This notice sets out a summary of the Dated: June 16, 2015. Administration, 10903 New Hampshire
use and burden associated with the William N. Parham, III, Ave., Silver Spring, MD 20993–0002,
following information collections. More Director, Paperwork Reduction Staff, Office 240–402–9077.
detailed information can be found in of Strategic Operations and Regulatory SUPPLEMENTARY INFORMATION:
each collection’s supporting statement Affairs.
I. Background
and associated materials (see [FR Doc. 2015–15126 Filed 6–18–15; 8:45 am]
ADDRESSES). BILLING CODE 4120–01–P FDA is announcing the availability of
a guidance for industry entitled ‘‘Size,
CMS–643 Hospice Survey and Shape, and Other Physical Attributes of
Deficiencies Report Form and DEPARTMENT OF HEALTH AND Generic Tablets and Capsules.’’ FDA is
Supporting Regulations HUMAN SERVICES concerned that the differences in size,
Under the PRA (44 U.S.C. 3501– shape, and other physical characteristics
3520), federal agencies must obtain Food and Drug Administration between a generic drug and the
approval from the Office of Management [Docket No. FDA–2013–N–1434] originator drug may affect patient
and Budget (OMB) for each collection of compliance and acceptability of
information they conduct or sponsor. Size, Shape, and Other Physical medication regimens or could lead to
The term ‘‘collection of information’’ is Attributes of Generic Tablets and medication errors. For example, studies
defined in 44 U.S.C. 3502(3) and 5 CFR Capsules; Guidance for Industry; show that tablet size and shape can
1320.3(c) and includes agency requests Availability affect ease of swallowing; generic tablets
or requirements that members of the that are significantly larger than their
public submit reports, keep records, or AGENCY: Food and Drug Administration, corresponding reference drug product
provide information to a third party. HHS. may be more difficult to swallow,
Section 3506(c)(2)(A) of the PRA ACTION: Notice. leading to potential adverse events as
requires federal agencies to publish a well as noncompliance with treatment
SUMMARY: The Food and Drug regimens. FDA is recommending that
60-day notice in the Federal Register
Administration (FDA) is announcing the generic manufacturers consider the size,
concerning each proposed collection of
availability of a guidance for industry shape, and other physical characteristics
information, including each proposed
entitled ‘‘Size, Shape, and Other of the originator drug when developing
extension or reinstatement of an existing
Physical Attributes of Generic Tablets a generic version.
collection of information, before
and Capsules.’’ This guidance discusses In the Federal Register of December
submitting the collection to OMB for
FDA recommendations for the size, 10, 2013 (78 FR 74154), this guidance
approval. To comply with this
shape, and other physical attributes of was published as a draft guidance. We
requirement, CMS is publishing this
generic tablets and capsules intended to have carefully reviewed and considered
notice.
be swallowed intact. FDA is concerned the comments that were received on the
Information Collection that differences in these physical draft guidance and have made editorial
1. Type of Information Collection characteristics between generic drugs changes primarily for clarification.
Request: Extension without change of a and the originator drug could affect This guidance is being issued
currently approved collection; Title of patient outcomes. consistent with FDA’s good guidance
Information Collection: Hospice Survey DATES: Submit either electronic or practices regulation (21 CFR 10.115).
and Deficiencies Report Form and written comments on Agency guidances The guidance represents the Agency’s
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Supporting Regulations; Use: We use at any time. current thinking on the size, shape, and
the information collected as the basis for ADDRESSES: Submit written requests for other physical attributes of generic
certification decisions for hospices that single copies of this guidance to the tablets and capsules. It does not
wish to obtain or retain participation in Division of Drug Information, Center for establish any rights for any person and
the Medicare and Medicaid programs. Drug Evaluation and Research, Food is not binding on FDA or the public.
The information is used by CMS and Drug Administration, 10001 New You can use an alternative approach if
regional offices, which have the Hampshire Ave., Hillandale Building, it satisfies the requirements of the
delegated authority to certify Medicare 4th Floor, Silver Spring, MD 20993– applicable statutes and regulations.
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![Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35367
II. Paperwork Reduction Act of 1995 DEPARTMENT OF HEALTH AND Survey on the Occurrence of Foodborne
HUMAN SERVICES Illness Risk Factors in Selected
This guidance contains information Institutional Foodservice and Retail
collection provisions that are subject to Food and Drug Administration Food Stores Facility Types (2015–2025)
review by the Office of Management and
[Docket No. FDA–2014–N–2033] (OMB Control Number 0910-NEW)
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– Agency Information Collection I. Background
3520). The collection of information Activities; Submission for Office of
requested in the guidance is covered From 1998–2008, FDA’s National
Management and Budget Review;
under FDA regulations at 21 CFR part Comment Request; Survey on the Retail Food Team conducted a study to
314 and approved under OMB control Occurrence of Foodborne Illness Risk measure trends in the occurrence of
Factors in Selected Institutional foodborne illness risk factors,
number 0910–0001.
Foodservice and Retail Food Stores preparation practices, and employee
III. Comments Facility Types behaviors most commonly reported to
the Centers for Disease Control and
Interested persons may submit either AGENCY: Food and Drug Administration, Prevention as contributing factors to
electronic comments regarding this HHS. foodborne illness outbreaks at the retail
document to http://www.regulations.gov ACTION: Notice. level. Specifically, data was collected by
or written comments to the Division of FDA Specialists in retail and
Dockets Management (see ADDRESSES). It SUMMARY: The Food and Drug foodservice establishments at 5-year
is only necessary to send one set of Administration (FDA) is announcing intervals (1998, 2003, and 2008) in order
comments. Identify comments with the that a proposed collection of to observe and document trends in the
docket number found in brackets in the information has been submitted to the occurrence of the following foodborne
Office of Management and Budget illness risk factors:
heading of this document. Received
(OMB) for review and clearance under
comments may be seen in the Division
the Paperwork Reduction Act of 1995. • Food from Unsafe Sources,
of Dockets Management between 9 a.m. • Poor Personal Hygiene,
DATES: Fax written comments on the
and 4 p.m., Monday through Friday, and
collection of information by July 20, • Inadequate Cooking,
will be posted to the docket at http://
www.regulations.gov.
2015. • Improper Holding/Time and
ADDRESSES: To ensure that comments on Temperature and
IV. Electronic Access the information collection are received, • Contaminated Equipment/Cross-
OMB recommends that written Contamination.
Persons with access to the Internet comments be faxed to the Office of
may obtain the document at either FDA developed reports summarizing
Information and Regulatory Affairs, the findings for each of the three data
http://www.fda.gov/Drugs/ OMB, Attn: FDA Desk Officer, FAX:
GuidanceCompliance collection periods (1998, 2003, and
202–395–7285, or emailed to oira_ 2008) (Refs. 1–3). Data from all three
RegulatoryInformation/Guidances/ submission@omb.eop.gov. All data collection periods were analyzed to
default.htm or http:// comments should be identified with the detect trends in improvement or
www.regulations.gov. OMB control number 0910–NEW and regression over time and to determine
Dated: June 15, 2015. title Survey on the Occurrence of whether progress had been made toward
Foodborne Illness Risk Factors in the goal of reducing the occurrence of
Leslie Kux,
Selected Institutional Foodservice and foodborne illness risk factors in selected
Associate Commissioner for Policy. Retail Food Stores Facility Types. Also
[FR Doc. 2015–15076 Filed 6–18–15; 8:45 am]
retail and foodservice facility types (Ref.
include the FDA docket number found 4).
BILLING CODE 4164–01–P in brackets in the heading of this
document. Using this 10-year survey as a
foundation, in 2013–2014, FDA initiated
FOR FURTHER INFORMATION CONTACT: FDA a new study in full service and fast food
PRA Staff, Office of Operations, Food restaurants. This study will span 10
and Drug Administration, 8455 years with additional data collections
Colesville Rd., COLE–14526, Silver planned for 2017–2018 and 2021–2022.
Spring, MD 20993–0002, PRAStaff@ FDA is proposing to collect data in
fda.hhs.gov. select institutional foodservice and
SUPPLEMENTARY INFORMATION: In retail food store facility types in 2015–
compliance with 44 U.S.C. 3507, FDA 2016. This proposed study will also
has submitted the following proposed span 10 years with additional data
collection of information to OMB for collections planned for 2019–2020 and
review and clearance. 2023–2024.
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Facility type Description
Healthcare Facilities ........................ Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible
populations as defined as follows:
• Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing
meals and transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in
the cafeteria may also be served to hospital staff and visitors).
• Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care
living setting such as nursing homes and assisted living facilities.
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Document Created: 2018-02-22 11:10:07
Document Modified: 2018-02-22 11:10:07
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Debra Catterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-3861; or Vilayat Sayeed, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-9077. | |
| FR Citation | 80 FR 35366 |
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