81 FR 44879 - Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
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 | 44879-44881 | |
| FR Document | 2016-16362 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Notices] [Pages 44879-44881] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16362] [[Page 44879]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1267] Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet the other conditions in section 503B. This guidance sets forth FDA's policies concerning the ``essentially a copy'' provision of section 503B. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by October 11, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by August 10, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-1267 for ``Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information collection issues to the Office of Management and Budget in the following ways: Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected]. All comments should be identified with the title, ``Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Submit written requests for single copies of the draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD, 301-796-3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' In 2013, the Drug Quality and Security Act, created a new section 503B of the Act, which describes a new category of [[Page 44880]] compounders called ``outsourcing facilities.'' Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from the following three sections of the FD&C Act: Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning labeling of drugs with adequate directions for use); Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)); and Section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503B of the Act is that ``the drug is not essentially a copy of one or more approved drugs'' (section 503B(a)(5)). Section 503B(d)(2) defines ``essentially a copy of an approved drug'' as: A drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing (section 503B(d)(2)(A)); or A drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug (section 503B(d)(2)(B)). This guidance sets forth FDA's policies concerning the ``essentially a copy'' provision of section 503B of the FD&C Act. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the ``essentially a copy'' provision of section 503B of the FD&C Act. 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. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this document, FDA invites comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Under the draft guidance, pursuant to section 503B(d)(2)(B) of the FD&C Act, if an outsourcing facility compounds a drug, the component of which is a bulk drug substance that is a component of an approved drug, there must be a change that produces a clinical difference for an individual patient as determined by the prescribing practitioner. If an outsourcing facility intends to rely on such a determination to establish that a compounded drug is not essentially a copy of an approved drug, the outsourcing facility should ensure that the determination is documented on the prescription or order (which may be a patient-specific prescription or a non-patient specific order) for the compounded drug. If a prescription or order does not make clear that the determination required by section 503B(d)(2)(B) has been made, the outsourcing facility may contact the prescriber or healthcare facility, and if the prescriber or healthcare facility confirms it, make a notation on the prescription or order that the prescriber has determined that the compounded product contains a change that produces a clinical difference for patient(s). The date of the conversation with the healthcare facility or prescriber should be included on the prescription or order. We estimate that annually a total of approximately 40 outsourcing facilities (``number of respondents'' in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded drug has a change that produces a clinical difference for an individual patient as compared to the comparable approved drug and that outsourcing facilities will document this determination on approximately 4,000 prescriptions or orders for compounded drugs (``total annual disclosures'' in table 1, line 1). We estimate that the consultation between the outsourcing facility and the prescriber or health care facility and adding a notation to each prescription or order that does not already document this determination will take approximately 3 minutes per prescription or order. In addition, if the outsourcing facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA's drug shortage list, the outsourcing facility should maintain documentation (e.g., a notation on the order for the compounded drug) regarding the status of the drug on FDA's drug shortage list at the time of compounding, distribution and dispensing. We estimate that a total of approximately 30 outsourcing facilities (``number of respondents'' in table 1, line 2) will document this information on approximately 3,000 prescriptions or orders for compounded drugs (``total annual disclosures'' in table 1, line 2). We estimate that checking FDA's drug shortage list and documenting this information will take approximately 2 minutes per prescription or order. An outsourcing facility should also maintain records of prescriptions or orders including notations that a prescriber has determined that the compounded drug has a change that produces a clinical difference for an individual patient. Because the time, effort, and financial resources necessary to comply with this collection of information would be incurred by licensed pharmacists and licensed physicians in the normal course of their activities, it is excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2). [[Page 44881]] FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of disclosures Total annual Average burden per Total hours respondents per respondent disclosures disclosure ---------------------------------------------------------------------------------------------------------------- Consultation between the 40 100 4,000 3 minutes......... 200 outsourcing facility and prescriber or health care facility, and the notation on the prescription or order documenting the prescriber's determination of clinical difference. Checking FDA's drug shortage 30 100 3,000 2 minutes......... 100 list and documenting on the prescription that the drug is in shortage. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: July 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16362 Filed 7-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44879
DEPARTMENT OF HEALTH AND confidential business information, such sheet and not in the body of your
HUMAN SERVICES as a manufacturing process. Please note comments and you must identify this
that if you include your name, contact information as ‘‘confidential.’’ Any
Food and Drug Administration information, or other information that information marked as ‘‘confidential’’
[Docket No. FDA–2016–D–1267]
identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
Compounded Drug Products That Are posted on http://www.regulations.gov. applicable disclosure law. For more
Essentially Copies of Approved Drug • If you want to submit a comment information about FDA’s posting of
Products Under Section 503B of the with confidential information that you comments to public dockets, see 80 FR
Federal Food, Drug, and Cosmetic Act; do not wish to be made available to the 56469, September 18, 2015, or access
Draft Guidance for Industry; public, submit the comment as a the information at: http://www.fda.gov/
Availability written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
HHS. read background documents or the
Written/Paper Submissions
ACTION: Notice of availability. electronic and written/paper comments
Submit written/paper submissions as received, go to http://
SUMMARY: The Food and Drug follows: www.regulations.gov and insert the
Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
docket number, found in brackets in the
announcing the availability of a draft written/paper submissions): Division of
heading of this document, into the
guidance for industry entitled Dockets Management (HFA–305), Food
‘‘Search’’ box and follow the prompts
‘‘Compounded Drug Products That Are and Drug Administration, 5630 Fishers
and/or go to the Division of Dockets
Essentially Copies of Approved Drug Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Management, 5630 Fishers Lane, Rm.
Products Under Section 503B of the 1061, Rockville, MD 20852.
Federal Food, Drug, and Cosmetic Act.’’ submitted to the Division of Dockets
Management, FDA will post your Submit comments on information
For a drug product compounded by an collection issues to the Office of
outsourcing facility to qualify for the comment, as well as any attachments,
except for information submitted, Management and Budget in the
exemptions under section 503B of the following ways:
marked and identified, as confidential,
Federal Food, Drug, and Cosmetic Act
if submitted as detailed in • Fax to the Office of Information and
(FD&C Act), it must not be essentially a Regulatory Affairs, OMB, Attn: FDA
copy of one or more approved drug ‘‘Instructions.’’
Instructions: All submissions received Desk Officer, FAX: 202–395–7285, or
products and must meet the other email to oira_submission@omb.eop.gov.
conditions in section 503B. This must include the Docket No. FDA–
2016–D–1267 for ‘‘Compounded Drug All comments should be identified with
guidance sets forth FDA’s policies the title, ‘‘Compounded Drug Products
concerning the ‘‘essentially a copy’’ Products That Are Essentially Copies of
Approved Drug Products Under Section That Are Essentially Copies of
provision of section 503B. Approved Drug Products Under Section
503B of the Federal Food, Drug, and
DATES: Although you can comment on 503B of the Federal Food, Drug, and
Cosmetic Act.’’ Received comments will
any guidance at any time (see 21 CFR be placed in the docket and, except for Cosmetic Act.’’
10.115(g)(5)), to ensure that the Agency those submitted as ‘‘Confidential Submit written requests for single
considers your comment on this draft Submissions,’’ publicly viewable at copies of the draft guidance to the
guidance before it begins work to http://www.regulations.gov or at the Division of Drug Information, Center for
finalize the guidance, submit either Division of Dockets Management Drug Evaluation and Research, Food
electronic or written comments on this between 9 a.m. and 4 p.m., Monday and Drug Administration, 10001 New
draft guidance by October 11, 2016. through Friday. Hampshire Ave., Hillandale Building,
Submit comments on information • Confidential Submissions—To 4th Floor, Silver Spring, MD 20993–
collection issues under the Paperwork submit a comment with confidential 0002. Send one self-addressed adhesive
Reduction Act of 1995 by August 10, information that you do not wish to be label to assist that office in processing
2016. made publicly available, submit your your requests. See the SUPPLEMENTARY
ADDRESSES: You may submit comments comments only as a written/paper INFORMATION section for electronic
as follows: submission. You should submit two access to the draft guidance document.
copies total. One copy will include the FOR FURTHER INFORMATION CONTACT: Sara
Electronic Submissions information you claim to be confidential Rothman, Center for Drug Evaluation
Submit electronic comments in the with a heading or cover note that states and Research, Food and Drug
following way: ‘‘THIS DOCUMENT CONTAINS Administration, 10903 New Hampshire
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The Ave., Bldg. 51, Rm. 5197, Silver Spring,
www.regulations.gov. Follow the Agency will review this copy, including MD, 301–796–3110.
instructions for submitting comments. the claimed confidential information, in SUPPLEMENTARY INFORMATION:
Comments submitted electronically, its consideration of comments. The
including attachments, to http:// second copy, which will have the I. Background
www.regulations.gov will be posted to claimed confidential information FDA is announcing the availability of
the docket unchanged. Because your redacted/blacked out, will be available a draft guidance for industry entitled
sradovich on DSK3GDR082PROD with NOTICES
comment will be made public, you are for public viewing and posted on http:// ‘‘Compounded Drug Products That Are
solely responsible for ensuring that your www.regulations.gov. Submit both Essentially Copies of Approved Drug
comment does not include any copies to the Division of Dockets Products Under Section 503B of the
confidential information that you or a Management. If you do not wish your Federal Food, Drug, and Cosmetic Act.’’
third party may not wish to be posted, name and contact information to be In 2013, the Drug Quality and Security
such as medical information, your or made publicly available, you can Act, created a new section 503B of the
anyone else’s Social Security number, or provide this information on the cover Act, which describes a new category of
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![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44881
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of reporting burden per Total hours
respondents per disclosures disclosure
respondent
Consultation between the outsourcing facility and pre- 40 100 4,000 3 minutes ....... 200
scriber or health care facility, and the notation on the
prescription or order documenting the prescriber’s deter-
mination of clinical difference.
Checking FDA’s drug shortage list and documenting on 30 100 3,000 2 minutes ....... 100
the prescription that the drug is in shortage.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access section 503A, including the terms • Mail/Hand delivery/Courier (for
Persons with access to the Internet ‘‘commercially available,’’ ‘‘essentially a written/paper submissions): Division of
may obtain the draft guidance at either copy of a commercially available drug,’’ Dockets Management (HFA–305), Food
http://www.fda.gov/Drugs/Guidance and ‘‘regularly or in inordinate and Drug Administration, 5630 Fishers
ComplianceRegulatoryInformation/ amounts.’’ Lane, Rm. 1061, Rockville, MD 20852.
DATES: Although you can comment on
• For written/paper comments
Guidances/default.htm or http://
any guidance at any time (see 21 CFR submitted to the Division of Dockets
www.regulations.gov.
10.115(g)(5)), to ensure that the Agency Management, FDA will post your
Dated: July 6, 2016. comment, as well as any attachments,
considers your comment on this draft
Leslie Kux,
guidance before it begins work to except for information submitted,
Associate Commissioner for Policy. finalize the guidance, submit either marked and identified, as confidential,
[FR Doc. 2016–16362 Filed 7–8–16; 8:45 am] electronic or written comments on this if submitted as detailed in
BILLING CODE 4164–01–P draft guidance by October 11, 2016. ‘‘Instructions.’’
Instructions: All submissions received
ADDRESSES: You may submit comments
must include the Docket No. FDA–
as follows: 2016–D–1309 for ‘‘Compounded Drug
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Electronic Submissions Products That Are Essentially Copies of
Submit electronic comments in the a Commercially Available Drug Product
Food and Drug Administration following way: Under Section 503A of the Federal
• Federal eRulemaking Portal: http:// Food, Drug, and Cosmetic Act.’’
[Docket No. FDA–2016–D–1309]
www.regulations.gov. Follow the Received comments will be placed in
Compounded Drug Products That Are instructions for submitting comments. the docket and, except for those
Essentially Copies of a Commercially Comments submitted electronically, submitted as ‘‘Confidential
Available Drug Product Under Section including attachments, to http:// Submissions,’’ publicly viewable at
503A of the Federal Food, Drug, and www.regulations.gov will be posted to http://www.regulations.gov or at the
Cosmetic Act; Draft Guidance for the docket unchanged. Because your Division of Dockets Management
Industry; Availability comment will be made public, you are between 9 a.m. and 4 p.m., Monday
solely responsible for ensuring that your through Friday.
AGENCY: Food and Drug Administration, comment does not include any • Confidential Submissions—To
HHS. confidential information that you or a submit a comment with confidential
ACTION: Notice of availability. third party may not wish to be posted, information that you do not wish to be
such as medical information, your or made publicly available, submit your
SUMMARY: The Food and Drug anyone else’s Social Security number, or comments only as a written/paper
Administration (FDA or the Agency) is confidential business information, such submission. You should submit two
announcing the availability of a draft as a manufacturing process. Please note copies total. One copy will include the
guidance for industry entitled that if you include your name, contact information you claim to be confidential
‘‘Compounded Drug Products That Are information, or other information that with a heading or cover note that states
Essentially Copies of a Commercially identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS
Available Drug Product Under Section comments, that information will be CONFIDENTIAL INFORMATION.’’ The
503A of the Federal Food, Drug, and posted on http://www.regulations.gov. Agency will review this copy, including
Cosmetic Act.’’ To qualify for • If you want to submit a comment the claimed confidential information, in
exemptions under section 503A of the with confidential information that you its consideration of comments. The
Federal Food, Drug, and Cosmetic Act do not wish to be made available to the second copy, which will have the
(the FD&C Act), a drug product must be claimed confidential information
sradovich on DSK3GDR082PROD with NOTICES
public, submit the comment as a
compounded by a licensed pharmacist written/paper submission and in the redacted/blacked out, will be available
or physician who does not compound manner detailed (see ‘‘Written/Paper for public viewing and posted on http://
regularly or in inordinate amounts any Submissions’’ and ‘‘Instructions’’). www.regulations.gov. Submit both
drug products that are essentially copies copies to the Division of Dockets
of a commercially available drug Written/Paper Submissions Management. If you do not wish your
product. This guidance sets forth FDA Submit written/paper submissions as name and contact information to be
policies regarding this provision of follows: made publicly available, you can
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Document Created: 2016-07-09 00:21:41
Document Modified: 2016-07-09 00:21:41
| 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 of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by October 11, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by August 10, 2016. | |
| Contact | Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD, 301-796-3110. | |
| FR Citation | 81 FR 44879 |
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