80 FR 18239 - Residual Solvents in Animal Drug Products; Questions and Answers; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 64 (April 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 64 (April 3, 2015)
| Page Range | 18239-18240 | |
| FR Document | 2015-07632 |
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)] [Notices] [Pages 18239-18240] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07632] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0566] Residual Solvents in Animal Drug Products; Questions and Answers; 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 #211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers.'' The questions and answers guidance addresses the United States Pharmacopeia (USP) General Chapter <467> Residual Solvents that applies to both human and veterinary drugs and to compendial and non-compendial drug products. This document answers questions regarding the Center for Veterinary Medicine's (CVM) implementation of USP <467> Residual Solvents. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. 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: Heather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0651, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of December 3, 2010 (75 FR 75482), FDA published the notice of availability for a draft guidance entitled ``Residual Solvents in Animal Drug Products; Questions and Answers'' giving interested persons until February [[Page 18240]] 1, 2011, to comment on the draft guidance. FDA received one comment on the draft guidance and that comment was considered as the guidance was finalized. Two of the questions and answers were revised, in addition to a few editorial changes made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2, 2010. On July 1, 2008, the USP implemented a requirement for the control of residual solvents in drug products marketed in the United States. Once implemented, the requirement, USP General Chapter <467> Residual Solvents, became a statutory requirement under section 501(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(b)). This document answers questions regarding CVM's implementation of USP <467> Residual Solvents. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Residual Solvents in Animal Drug Products; Questions and Answers.'' 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. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032; the collections of information in section 512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB control number 0910-0669. IV. 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. V. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: March 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07632 Filed 4-2-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18239
comments should be received within 30 present in the dust or dust cloud on whether to propose a rule to add the
days of this notice. September 11, 2001 or who worked, condition, to not to add the condition,
resided, or attended school, childcare, or to seek a recommendation from the
Proposed Project
or adult daycare in the New York City Scientific/Technical Advisory
World Trade Center Health Program disaster area (survivors). Committee (STAC).
Petition for the Addition of a New WTC- PHS Act § 3312(a)(3) identifies a list The petition form is amended slightly
Related Health Condition for Coverage of health conditions for which to reflect a WTC Health Program policy
under the World Trade Center (WTC) individuals who are enrolled in the change. The current form asks
Health Program (OMB No. 0920–0929, WTC Health Program may be monitored respondents to offer reference to ‘‘a
expiration 04/30/2015)—Revision— peer-reviewed, published,
or treated. PHS Act § 3312(a)(6)(B)
Centers for Disease Control and epidemiologic study.’’ The revised form
specifies that interested parties may
Prevention (CDC), National Institutes for will ask respondents to reference ‘‘peer-
petition the Administrator of the WTC
Occupational Safety and Health reviewed, published, epidemiologic
Health Program to request that a new
(NIOSH). and/or direct observational studies.’’
health condition be added to the List of
Background and Brief Description WTC-Related Health Conditions in 42 The submission of a petition is purely
Title I of the James Zadroga 9/11 CFR 88.1. To aid the petitioner, the voluntary, and is not required or
Health and Compensation Act of 2010 WTC Health Program provides a otherwise compelled by NIOSH or the
(Pub. L. 111–347), amended the Public petition form to be completed and then WTC Health Program.
Health Service Act (PHS Act) to add sent to the Administrator for review. NIOSH expects to receive no more
Title XXXIII establishing the WTC However, the petitioner is not required than 20 submissions annually.
Health Program within the Department to use the form, and may submit a Petitioners include prospective and
of Health and Human Services (HHS). petition in a different format, provided enrolled WTC responders, screening-
The WTC Health Program provides it contains all of the data elements eligible survivors, certified-eligible
medical monitoring and treatment requested on the form. survivors, or members of groups who
benefits to eligible firefighters and Data elements include the interested advocate on behalf of responders or
related personnel, law enforcement party’s name, contact information, survivors, such as physicians. It is
officers, and rescue, recovery, and signature, and a statement about the estimated that an individual spends an
cleanup workers who responded to the medical basis for the relationship/ average of 40 hours gathering
September 11, 2001, terrorist attacks in association between the 9/11 exposure information to substantiate a request to
New York City, at the Pentagon, and in and the proposed health condition, add a health condition and assembling
Shanksville, Pennsylvania (responders), which the Administrator of the WTC the petition. The total estimated
and to eligible persons who were Health Program will use to determine annualized burden hours are 800.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (hours)
Responder/Survivor/Advocate (physician) ...... Petition for the addition of health conditions 20 1 40
Leroy A. Richardson, availability of a guidance for industry the SUPPLEMENTARY INFORMATION section
Chief, Information Collection Review Office, #211 entitled ‘‘Residual Solvents in for electronic access to the guidance
Office of Scientific Integrity, Office of the Animal Drug Products; Questions and document.
Associate Director for Science, Office of the Answers.’’ The questions and answers Submit electronic comments on the
Director, Centers for Disease Control and guidance addresses the United States guidance to http://www.regulations.gov.
Prevention. Pharmacopeia (USP) General Chapter Submit written comments to the
[FR Doc. 2015–07670 Filed 4–2–15; 8:45 am] <467> Residual Solvents that applies to Division of Dockets Management (HFA–
BILLING CODE 4163–18–P both human and veterinary drugs and to 305), Food and Drug Administration,
compendial and non-compendial drug 5630 Fishers Lane, Rm. 1061, Rockville,
products. This document answers MD 20852.
DEPARTMENT OF HEALTH AND questions regarding the Center for
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT:
Veterinary Medicine’s (CVM) Heather Longstaff, Center for Veterinary
Food and Drug Administration implementation of USP <467> Residual Medicine (HFV–145), Food and Drug
Solvents. Administration, 7500 Standish Pl.,
[Docket No. FDA–2010–D–0566] DATES: Submit either electronic or Rockville, MD 20855, 240–402–0651,
written comments on Agency guidances email: heather.longstaff@fda.hhs.gov.
Residual Solvents in Animal Drug at any time. SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Products; Questions and Answers;
ADDRESSES: Submit written requests for
Guidance for Industry; Availability I. Background
single copies of the guidance to the
AGENCY: Food and Drug Administration, Communications Staff (HFV–12), Center In the Federal Register of December 3,
HHS. for Veterinary Medicine, Food and Drug 2010 (75 FR 75482), FDA published the
ACTION: Notice. Administration, 7519 Standish Pl., notice of availability for a draft guidance
Rockville, MD 20855. Send one self- entitled ‘‘Residual Solvents in Animal
SUMMARY: The Food and Drug addressed adhesive label to assist that Drug Products; Questions and Answers’’
Administration (FDA) is announcing the office in processing your request. See giving interested persons until February
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![18240 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
1, 2011, to comment on the draft V. Electronic Access Abstract: HRSA’s Bureau of Health
guidance. FDA received one comment Workforce (BHW) is committed to
Persons with access to the Internet
on the draft guidance and that comment improving the health of the nation’s
may obtain the guidance at either
was considered as the guidance was underserved communities and
http://www.fda.gov/AnimalVeterinary/
finalized. Two of the questions and vulnerable populations by developing,
GuidanceComplianceEnforcement/
answers were revised, in addition to a implementing, evaluating, and refining
GuidanceforIndustry/default.htm or
few editorial changes made to improve programs that strengthen the nation’s
http://www.regulations.gov.
clarity. The guidance announced in this health workforce. The Department of
notice finalizes the draft guidance dated Dated: March 30, 2015. Health and Human Services relies on
December 2, 2010. Leslie Kux, two federal shortage designations to
On July 1, 2008, the USP Associate Commissioner for Policy. identify and dedicate resources to areas
implemented a requirement for the [FR Doc. 2015–07632 Filed 4–2–15; 8:45 am] and populations in greatest need of
control of residual solvents in drug BILLING CODE 4164–01–P providers: Health Professional Shortage
products marketed in the United States. Area (HPSA) designations and
Once implemented, the requirement, Medically Underserved Area/Medically
USP General Chapter <467> Residual DEPARTMENT OF HEALTH AND Underserved Population (MUA/P)
Solvents, became a statutory HUMAN SERVICES designations. HPSA designations are
requirement under section 501(b) of the geographic areas, population groups,
Federal Food, Drug, and Cosmetic Act Health Resources and Services and facilities that are experiencing a
(the FD&C Act) (21 U.S.C. 351(b)). This Administration shortage of health professionals. MUA/
document answers questions regarding P designations are areas, or populations
CVM’s implementation of USP <467> Agency Information Collection within areas, that are experiencing a
Residual Solvents. Activities: Proposed Collection: Public shortage of health care services. MUAs
Comment Request are designated for the entire population
II. Significance of Guidance
of a particular geographic area. MUP
This level 1 guidance is being issued AGENCY: Health Resources and Services
designations are limited to particular
consistent with FDA’s good guidance Administration, HHS.
groups of underserved people within an
practices regulation (21 CFR 10.115). ACTION: Notice. area. These designations are currently
The guidance represents the current used in a number of departmental
thinking of FDA on ‘‘Residual Solvents SUMMARY: In compliance with the
programs that provide both federal and
in Animal Drug Products; Questions and requirement for opportunity for public
state government grant/program benefits
Answers.’’ It does not establish any comment on proposed data collection
for communities, health care facilities,
rights for any person and is not binding projects (Section 3506(c)(2)(A) of the
and providers. BHW has the
on FDA or the public. You can use an Paperwork Reduction Act of 1995), the responsibility for designating and de-
alternative approach if it satisfies the Health Resources and Services designating HPSAs and MUA/Ps on
requirements of the applicable statutes Administration (HRSA) announces behalf of the Secretary.
and regulations. plans to submit an Information HPSA designations are required to be
Collection Request (ICR), described reviewed and updated regularly to
III. Paperwork Reduction Act of 1995 below, to the Office of Management and reflect current data. Individual states—
This guidance refers to previously Budget (OMB). Prior to submitting the through their Primary Care Office
approved collections of information ICR to OMB, HRSA seeks comments (PCO)—have primary responsibility for
found in FDA regulations. These from the public regarding the burden initiating an application for a new or
collections of information are subject to estimate, below, or any other aspect of updated HPSA designation, or
review by the Office of Management and the ICR. withdrawing HPSAs that no longer meet
Budget (OMB) under the Paperwork DATES: Comments on this Information the designation criteria. HRSA reviews
Reduction Act of 1995 (44 U.S.C. 3501– Collection Request must be received no the application and makes the final
3520). The collections of information in later than June 8, 2015. determination on the HPSA designation.
21 CFR part 514 have been approved ADDRESSES: Submit your comments to Requests come from the PCOs who have
under OMB control number 0910–0032; paperwork@hrsa.gov or mail the HRSA access to the online application and
the collections of information in section Information Collection Clearance review system, Shortage Designation
512(n)(1) of the FD&C Act (21 U.S.C. Officer, Room 10C–03, Parklawn Management System (SDMS). Requests
360k) have been approved under OMB Building, 5600 Fishers Lane, Rockville, that come from other sources are
control number 0910–0669. MD 20857. referred to the PCOs for their review and
concurrence. In addition, interested
IV. Comments FOR FURTHER INFORMATION CONTACT: To
parties, including the Governor, the
Interested persons may submit either request more information on the State Primary Care Association, and
electronic comments regarding this proposed project or to obtain a copy of state professional associations are
document to http://www.regulations.gov the data collection plans and draft notified of each request submitted for
or written comments to the Division of instruments, email paperwork@hrsa.gov their comments and recommendations.
Dockets Management (see ADDRESSES). It or call the HRSA Information Collection In order to obtain a federal shortage
is only necessary to send one set of Clearance Officer at (301) 443–1984. designation for an area, population, or
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments. Identify comments with the SUPPLEMENTARY INFORMATION: When facility, PCOs must submit a shortage
docket number found in brackets in the submitting comments or requesting designation application through SDMS
heading of this document. Received information, please include the for review and approval by BHW. Both
comments may be seen in the Division information request collection title for the HPSA and MUA/P application
of Dockets Management between 9 a.m. reference. request local, state, and national data on
and 4 p.m., Monday through Friday, and Information Collection Request Title: the population that is experiencing a
will be posted to the docket at http:// Shortage Designation Management shortage of health professionals and the
www.regulations.gov. System OMB No. 0906–xxxx–New. number of health professionals relative
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Document Created: 2015-12-18 15:28:57
Document Modified: 2015-12-18 15:28:57
| 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 | Heather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0651, email: [email protected] | |
| FR Citation | 80 FR 18239 |
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