82 FR 4351 - How To Prepare a Pre-Request for Designation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4351-4353 | |
| FR Document | 2017-00629 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4351-4353] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00629] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0040] How To Prepare a Pre-Request for Designation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation. This draft guidance is not final nor is it in effect at this time. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 13, 2017. Submit either written or electronic comments on this collection of information by March 14, 2017. 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-2017-D-0040 for ``How to Prepare a Pre-Request for Designation (Pre-RFD); Draft Guidance for Industry.'' 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, ``How to Prepare a Pre-Request for Designation (Pre-RFD); Draft Guidance for Industry.'' Submit written requests for single copies of the draft guidance document entitled ``How to Prepare a Pre-Request for Designation (Pre- RFD)'' to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847- 8619. See the SUPPLEMENTARY [[Page 4352]] INFORMATION section for information on electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, or via email at [email protected]. SUPPLEMENTARY INFORMATION: I. Background Since its establishment on December 24, 2002, OCP has served as a resource for sponsors at various stages of development of their product. Sponsors often seek OCP feedback on whether their medical product will be regulated as a drug, a device, a biologic, or a combination product, and which FDA medical product Center (CDER, CBER, or CDRH) will regulate it, if it is a non-combination product, or will have the primary jurisdiction for the premarket review and regulation of the product, if it is a combination product. There are two ways that a sponsor can receive such feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor's product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR part 3, and OCP has issued a guidance about this process (see ``How to Write a Request for Designation'' at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second more flexible option is for a sponsor to submit an inquiry to OCP to receive a preliminary jurisdictional assessment, which is not binding. Many sponsors seek to utilize the flexibility of more approachable ways to interact with OCP and the medical product Agency Centers to obtain feedback from the Agency before submitting a marketing application to FDA. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of this process, which will now be called the ``Pre-Request for Designation (Pre-RFD) Program.'' This draft guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD. II. Significance of Guidance 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 how to prepare a Pre-RFD. 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 Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3502), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information 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 following collection of information, FDA invites comments on these 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. Draft Guidance for Industry; How To Prepare a Pre-Request for Designation (Pre-RFD) This draft guidance describes how to prepare a Pre-RFD. The guidance provides recommendations regarding the information that should be submitted in a Pre-RFD request and procedures that should be followed for meetings or conference calls between OCP, the Centers, and industry representatives or sponsors. The proposed collections of information are necessary to allow the Agency to receive Pre-RFD requests in order to implement this voluntary submission program. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total annual burden per Activity respondents responses per responses response (in Total hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Pre-RFD submissions............. 136 1 136 12 1,632 Pre-RFD meetings................ 136 1 136 1 136 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,768 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are product sponsors and industry representatives subject to FDA's laws and regulations. FDA estimates that it will receive approximately 136 Pre-RFDs annually. The Agency reached this estimate through its experience with the formal Request for Designation (RFD) program, by reviewing the number of informal, pre-RFD inquiries from sponsors that the Agency received over the past 3 years. Based on FDA's experience with [[Page 4353]] these informal, Pre-RFD inquiries, FDA expects the proposed Pre-RFD program to be utilized as a viable program in the future and expects that the number of Pre-RFDs will increase initially to approximately 180 submissions. FDA estimates from past experience with informal Pre-RFD inquiries that the complete process involved with preparing the Pre-RFD submission takes approximately 12 hours and an additional 1 hour for meetings. This average is based upon estimates by FDA administrative and technical staff who are familiar with the information collection relating to informal, Pre-RFD inquiries, who have consulted and advised sponsors and industry representatives on the information collection, and who have reviewed the documentation submitted. Therefore, the total reporting burden hours is estimated to be 1,768 hours. Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Total burden Number of respondents hours Hourly wage Total cost annualized rate annualized ---------------------------------------------------------------------------------------------------------------- 136.......................................................... 13 $33.26 $58,803.68 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Assuming an hourly wage plus benefit rate of $33.26,\1\ the result is a cost of $432.38 per respondent. The estimated submission cost of $432.38 multiplied by 136 submissions per year equals $58,803.68, which is the estimated aggregated industry reporting cost annualized. --------------------------------------------------------------------------- \1\ Wage is based on the 2015 Bureau of Labor Statistic's survey, National Industry Specific Occupational Employment and Wage Estimate, for standard occupational code 13-1041, compliance officer in pharmaceutical and medicine manufacturing (http://www.bls.gov/oes/current/oes131041.htm). --------------------------------------------------------------------------- This draft guidance also refers to previously approved information collections found in FDA regulations. The collections of information in 21 CFR part 3 are approved under OMB control number 0910-0523. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/RegulatoryInformation/Guidances/ucm534661.htm. Dated: January 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00629 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4351
comment. In general, combination Submit either written or electronic made publicly available, submit your
product policy decisions reached by the comments on this collection of comments only as a written/paper
Council are communicated and information by March 14, 2017. submission. You should submit two
implemented in accordance with FDA’s ADDRESSES: You may submit comments copies total. One copy will include the
good guidance practices regulation (21 as follows: information you claim to be confidential
CFR 10.115) or notice and comment with a heading or cover note that states
procedures. Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Dated: January 9, 2017.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
Leslie Kux, • Federal eRulemaking Portal: http:// the claimed confidential information, in
Associate Commissioner for Policy. www.regulations.gov. Follow the its consideration of comments. The
[FR Doc. 2017–00646 Filed 1–12–17; 8:45 am] instructions for submitting comments. second copy, which will have the
BILLING CODE 4164–01–P Comments submitted electronically, claimed confidential information
including attachments, to http:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on http://
DEPARTMENT OF HEALTH AND the docket unchanged. Because your www.regulations.gov. Submit both
HUMAN SERVICES comment will be made public, you are copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
Food and Drug Administration
comment does not include any name and contact information to be
[Docket No. FDA–2017–D–0040] confidential information that you or a made publicly available, you can
third party may not wish to be posted, provide this information on the cover
How To Prepare a Pre-Request for such as medical information, your or sheet and not in the body of your
Designation; Draft Guidance for anyone else’s Social Security number, or comments and you must identify this
Industry; Availability confidential business information, such information as ‘‘confidential.’’ Any
AGENCY: Food and Drug Administration, as a manufacturing process. Please note information marked as ‘‘confidential’’
HHS. that if you include your name, contact will not be disclosed except in
information, or other information that accordance with 21 CFR 10.20 and other
ACTION: Notice of availability. applicable disclosure law. For more
identifies you in the body of your
SUMMARY: The Food and Drug comments, that information will be information about FDA’s posting of
Administration (FDA or Agency) is posted on http://www.regulations.gov. comments to public dockets, see 80 FR
announcing the availability of a draft • If you want to submit a comment 56469, September 18, 2015, or access
guidance for industry entitled ‘‘How to with confidential information that you the information at: http://www.fda.gov/
Prepare a Pre-Request for Designation do not wish to be made available to the regulatoryinformation/dockets/
(Pre-RFD).’’ The purpose of this public, submit the comment as a default.htm.
guidance is to explain the Pre-RFD written/paper submission and in the Docket: For access to the docket to
process at the FDA Office of manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Combination Products (OCP), describe
received, go to http://
and help a sponsor understand the type Written/Paper Submissions www.regulations.gov and insert the
of information that the sponsor should
Submit written/paper submissions as docket number, found in brackets in the
include in a Pre-RFD, and assist
follows: heading of this document, into the
sponsors in obtaining a preliminary • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
assessment from FDA through the Pre- written/paper submissions): Division of and/or go to the Division of Dockets
RFD process. The Pre-RFD process is Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
available to provide informal, non- and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
binding feedback regarding the Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information
regulatory identity or classification of a • For written/paper comments collection issues to the Office of
human medical product as a drug, submitted to the Division of Dockets Management and Budget in the
device, biological product, or Management, FDA will post your following ways:
combination product. In addition, this comment, as well as any attachments, • Fax to the Office of Information and
informal process provides information except for information submitted, Regulatory Affairs, OMB, Attn: FDA
about a non-combination or marked and identified, as confidential, Desk Officer, FAX: 202–395–7285, or
combination product’s assignment to if submitted as detailed in email to oira_submission@omb.eop.gov.
the appropriate Agency Center (Center ‘‘Instructions.’’ All comments should be identified with
for Drug Evaluation and Research Instructions: All submissions received the title, ‘‘How to Prepare a Pre-Request
(CDER), Center for Devices and must include the Docket No. FDA– for Designation (Pre-RFD); Draft
Radiological Health (CDRH), or Center 2017–D–0040 for ‘‘How to Prepare a Pre- Guidance for Industry.’’
for Biologics Evaluation and Research Request for Designation (Pre-RFD); Draft Submit written requests for single
(CBER)) for premarket review and Guidance for Industry.’’ Received copies of the draft guidance document
regulation. This draft guidance is not comments will be placed in the docket entitled ‘‘How to Prepare a Pre-Request
final nor is it in effect at this time. and, except for those submitted as for Designation (Pre-RFD)’’ to the Office
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly of Combination Products, Food and
any guidance at any time (see 21 CFR viewable at http://www.regulations.gov Drug Administration, 10903 New
10.115(g)(5)), to ensure that the Agency or at the Division of Dockets Hampshire Ave., Bldg. 32, Rm. 5129,
considers your comment of this draft Management between 9 a.m. and 4 p.m., Silver Spring, MD 20993–0002. Send
guidance before it begins work on the Monday through Friday. one self-addressed adhesive label to
final version of the guidance, submit • Confidential Submissions—To assist that office in processing your
either electronic or written comments submit a comment with confidential request, or fax your request to 301–847–
on the draft guidance by April 13, 2017. information that you do not wish to be 8619. See the SUPPLEMENTARY
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![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4353
these informal, Pre-RFD inquiries, FDA complete process involved with informal, Pre-RFD inquiries, who have
expects the proposed Pre-RFD program preparing the Pre-RFD submission takes consulted and advised sponsors and
to be utilized as a viable program in the approximately 12 hours and an industry representatives on the
future and expects that the number of additional 1 hour for meetings. information collection, and who have
Pre-RFDs will increase initially to This average is based upon estimates reviewed the documentation submitted.
approximately 180 submissions. by FDA administrative and technical
FDA estimates from past experience staff who are familiar with the Therefore, the total reporting burden
with informal Pre-RFD inquiries that the information collection relating to hours is estimated to be 1,768 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Total burden Hourly Total cost
Number of respondents hours wage rate annualized
annualized
136 ............................................................................................................................................... 13 $33.26 $58,803.68
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Assuming an hourly wage plus benefit guidance for industry entitled ‘‘Multiple third party may not wish to be posted,
rate of $33.26,1 the result is a cost of Endpoints in Clinical Trials.’’ This draft such as medical information, your or
$432.38 per respondent. The estimated guidance provides sponsors and review anyone else’s Social Security number, or
submission cost of $432.38 multiplied staff with the Agency’s thinking about confidential business information, such
by 136 submissions per year equals the problems posed by multiple as a manufacturing process. Please note
$58,803.68, which is the estimated endpoints in the analysis and that if you include your name, contact
aggregated industry reporting cost interpretation of study results and how information, or other information that
annualized. these problems can be managed in identifies you in the body of your
This draft guidance also refers to clinical trials for human drugs, comments, that information will be
previously approved information including drugs subject to licensing as posted on http://www.regulations.gov.
collections found in FDA regulations. biological products. Most clinical trials • If you want to submit a comment
The collections of information in 21 performed in drug development contain with confidential information that you
CFR part 3 are approved under OMB multiple endpoints to assess the effects do not wish to be made available to the
control number 0910–0523. of the drug and to document the ability public, submit the comment as a
of the drug to favorably affect one or written/paper submission and in the
IV. Electronic Access
more disease characteristics. The manner detailed (see ‘‘Written/Paper
Persons with access to the Internet purpose of this guidance is to describe Submissions’’ and ‘‘Instructions’’).
may obtain the document at http://www. various strategies for grouping and
fda.gov/RegulatoryInformation/ Written/Paper Submissions
ordering endpoints for analysis and
Guidances/ucm534661.htm. applying some well-recognized Submit written/paper submissions as
Dated: January 9, 2017. statistical methods for managing follows:
multiplicity within a study to control • Mail/Hand delivery/Courier (for
Leslie Kux,
the chance of making erroneous written/paper submissions): Division of
Associate Commissioner for Policy.
conclusions about a drug’s effects. Dockets Management (HFA–305), Food
[FR Doc. 2017–00629 Filed 1–12–17; 8:45 am] and Drug Administration, 5630 Fishers
DATES: Although you can comment on
BILLING CODE 4164–01–P Lane, Rm. 1061, Rockville, MD 20852.
any guidance at any time (see 21 CFR • For written/paper comments
10.115(g)(5)), to ensure that the Agency submitted to the Division of Dockets
DEPARTMENT OF HEALTH AND considers your comment on this draft Management, FDA will post your
HUMAN SERVICES guidance before it begins work on the comment, as well as any attachments,
final version of the guidance, submit except for information submitted,
Food and Drug Administration either electronic or written comments marked and identified, as confidential,
[Docket No. FDA–2016–D–4460] on the draft guidance by March 14, if submitted as detailed in
2017. ‘‘Instructions.’’
Multiple Endpoints in Clinical Trials; ADDRESSES: You may submit comments Instructions: All submissions received
Draft Guidance for Industry; as follows: must include the Docket No. FDA–
Availability 2016–D–4460 for ‘‘Multiple Endpoints
Electronic Submissions in Clinical Trials; Draft Guidance for
AGENCY: Food and Drug Administration,
HHS. Submit electronic comments in the Industry; Availability.’’ Received
following way: comments will be placed in the docket
ACTION: Notice of availability. • Federal eRulemaking Portal: http:// and, except for those submitted as
SUMMARY: The Food and Drug www.regulations.gov. Follow the ‘‘Confidential Submissions,’’ publicly
instructions for submitting comments.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Administration (FDA or Agency) is viewable at http://www.regulations.gov
announcing the availability of a draft Comments submitted electronically, or at the Division of Dockets
including attachments, to http:// Management between 9 a.m. and 4 p.m.,
1 Wage is based on the 2015 Bureau of Labor www.regulations.gov will be posted to Monday through Friday.
Statistic’s survey, National Industry Specific the docket unchanged. Because your • Confidential Submissions—To
Occupational Employment and Wage Estimate, for comment will be made public, you are submit a comment with confidential
standard occupational code 13–1041, compliance
officer in pharmaceutical and medicine
solely responsible for ensuring that your information that you do not wish to be
manufacturing (http://www.bls.gov/oes/current/ comment does not include any made publicly available, submit your
oes131041.htm). confidential information that you or a comments only as a written/paper
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Document Created: 2017-01-13 02:45:09
Document Modified: 2017-01-13 02:45:09
| 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 of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 13, 2017. Submit either written or electronic comments on this collection of information by March 14, 2017. | |
| Contact | Leigh Hayes, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, or via email at [email protected] | |
| FR Citation | 82 FR 4351 |
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